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8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 111 - dietary supplements (misc) 21 cfr part 801 - labeling 21 cfr part 807 - establishment registra. & device listing 21 cfr part 812 - investigational device exemptions 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2017 2018 2019 2020 accelerated life and stability testing acceptance criteria accessories (product) accreditation bodies accuracy (general term) accuracy of a measurement device acronyms active medical device address changes adverse event reporting advisory notices aea - aerospace experience auditor aerospace (general) aerospace standards and regulations aiag (automotive industry action group) aiag manual(s) alarms (visual and/or audible) aluminum (general topics) amdd - asean medical device directive ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) andons annex v/vii annex x annual layout inspection anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing ansi z1.4 - inspection by attributes anvisa api (american petroleum institute) api q1 - oil industry quality management system (qms) api q2 - oil and gas industry service suppliers app (mobile device software) applicable clauses documents legal requirements etc. approvals apqp (advanced product quality planning) aql (acceptable quality level) as9100 - aerospace quality management systems as9100 revision d (2016) as9102 - aerospace first article inspection (fai) as9110 - aerospace maintenance quality systems as9120 - aerospace qms requirements for distributors as9146 (foreign object damage (fod) prevention program) aspects and impacts (environmental) asq (american society for quality) asq certifications assembly (general term) astm (american society for testing and materials) attribute data attribute data msa (measurement system analysis) audit checklist audit man-days audit nonconformances and findings audit observation auditor qualification requirements and certifications auditors (general topics) auditor training audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia tga authorized representative autoclaves automotive (general) automotive industry barcoding (upca - upce - ean8 - ean 13 - qr code) batch manufacturing (general) batch production battery (electric batteries) battery powered devices benefit(s) best practices bias study (measurement) bioburden biocompatibility biocompatibility requirements biocompatibility testing bluetooth data communications boeing books brazil brochures business processes business process maps cables (electrical and related such as signal carriers) cables (general) calibration (general topics) calibration (metrology) laboratories calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration software calibration verification calipers canada canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (part dimensions from a process or machine) career changes careers catheters cba (certified biomedical auditor) cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of conformance (c of c) certificate of free sale certificates (general) certification audits certification bodies (cb) certification certificate (content) certification process certifications (professional) certifications (to a standard) certified calibration technician (cct) cfda (china food and drugs administration) change(s) (general) change control change management change notice (process or product) aka pcn charts checklist or check sheet china chrysler class i exempt medical device classification(s) of parts or products class iii medical device class ii medical device class i medical device cleaning methods and processes cleaning validation cleanrooms cleanroom validation clinical data management (cdm) clinical evaluations and reports clinical trials and studies and investigations cloud computing cmdcas (canadian med device conformity assmnt system) cmk cmm (coordinate measuring machine) cnc machine shop cnc machining cnc software coatings cofepris (mexico's medical device and ivd oversight) color (general) combination devices and related rules combination drug-device products communications community discussions company name change company organization company policies company vision or strategy comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance (general) components concessions confidential data conformity assessments connectors (electrical) construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) contamination control context of the organization contingency plans continuous improvement contract audits and contract auditing contract manufacturing contract review and approval contracts and agreements (general) contract services control chart limits control charts (general) controlled documents control limits control methods control plans controls convenience kits (medical device) copyrights correction and removal (fda term) corrective action (ca) corrective action request (car) corrective action systems cost estimation cots (commercial off-the-shelf) counterfeiting control counterfeit parts and products covegratulations cpk (related to process capability) cqa (certified quality auditor) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment cqi requirements (customer specific requirements) creepage distance critical characteristics critical parts and components critical processes (general) critical suppliers customer approval customer complaints and customer found nonconformance customer feedback customer requirements customer satisfaction customer service customer specific requirements (csr) data (general) data (import from and export to applications) data analysis databases data collection and/or entry data control data integrity data security dates (general) datum (gd&t) datum feature references dcma (defense contract management agency) deaths declaration of conformity definitions delivery of products and services dental topics design and development design changes design control design history file (dhf) design history record (dhr) design inputs and outputs design master records (dmr) design of experiments (doe) design validation design verification design verification testing (dvt - medical devices) deviations from a print or requirement device history record (dhr) device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diagnostic devices (medical) diameter measurement dielectric strength dies dietary supplement differences (general) dimensional inspection dimensions displays (video monitors) distribution centers distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits document classification document content & structure document control document control (electronic) document control software documented procedures (requirements for) document identification and numbering document references document retention document revisions and changes documents and documentation (general) documents of external origin dod (department of defense) draft documents drawing (also see prints) drug master file (dmf) easa (european aviation safety agency) easa part - 145 maintenance organisation approval effectiveness efficiency electrical components parts and products electrical safety electronic components parts assemblies and products electronic documents forms and templates electronic records electronic signatures and approvals elsmar email (general) emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee satisfaction employee training and qualifications en 60601 - medical electrical equipment endoscopic equipment engineering change notice (ecn) engineering change order (eco) engineering change request (ecr) engineering changes engineering drawings environmental management systems epoxy (general) equipment qualification and validation equivalent medical devices error proofing escalation process essential performance essential requirements checklist etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization eu 2017/745 europe european medical device regulations european union european union medical device directives (mdd) european union regulations and standards evidence examinations (course or certification tests) exclusions of clauses in a standard exemptions expiration date exports and exporting external audits and auditors external communications external document control external documents - prints standards etc. external issues external laboratories (including calibration and testing) external processes external services faa (federal aviation administration) faa form 8130 faa part 145 (certified repair station) faa repair stations failure modes fda (food and drug administration) fda guidance fda news fda requirements feasibility analysis and review final inspection and/or testing first article inspection (fai) first article inspection report (fair) fishbone diagram fixture(s) flammability flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food safety ford motor company ford q1 foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for sale forum software (general) forum software instructions forum software problems forum suggestions (general) fraud functional requirements furls (fda's electronic registration and listing system) gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gamp (good automated manufacturing practice) gamp validation procedures gap analysis gd&t (geometric dimensioning & tolerancing) gdp (good documentation practices) gdpr (eu general data protection regulation) general motors (gm) germany glp (good laboratory practices) gmdn (global medical device nomenclature) gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) gui (graphic user interface) guidance documents harmonization of standards hazard analysis hazard identification and risk assessment health (general) health canada heat treatment hipaa (health insurance portability and accountability act) hipaa rules obligations requirements histogram history home healthcare human tissues and organs humidity control hypothesis test analysis iaf (international accreditation forum) iaqg (international aerospace quality group) iatf (international automotive task force) iatf 16949:2016 identification (products and parts etc) identification and traceability (general) iec 60335 - household electrical appliance safety iec 60601 - medical electrical equipment iec 60950 (information technology equipment - safety) iec 61000 - electromagnetic compatibility iec 61010 - safety requirements for electrical equipment iec 61326 - laboratory equipment emc requirements iec 62133 - secondary cells and batteries safety requirements iec 62304 - medical device software life cycle processes iec 62366 - medical device usability engineering iec 62366-1:2015 medical device usability imdrf (international medical devices regulators forum) imds (international material data system) immunity tests implantable medical devices (imd) implementation of a standard in a company implementing a qms implementing iatf 16949 implementing iso 9001 imports and importation improvement in-house calibration in-process inspection incoming inspection (also see receiving inspection) india indian health ministry information security infrastructure infusion pumps and devices injection medical devices injection molding inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records inspectors installation qualification (iq) instructions for use (ifu) integrated management systems interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal issues internal laboratory international standards interpretations interviews and interview questions investigational testing authorizations (ita) investigational use only (iuo) ishikawa diagram isms (information security management system) iso (int'l organization for standardization) iso 2859 - sampling for inspection by attributes iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11137 - medical device radiation sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14155 - good clinical investigation practices iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 17020 - criteria for bodies performing inspection iso 17025 - testing and calibration laboratories iso 19011 - quality (qms) and ems audits iso 26000 - social responsibility iso 27001 - information security management system (isms) iso 31010 - risk assessment techniques iso 45001 - occupational health and safety management standard israel itar (international traffic in arms regulations) ivd (in vitro diagnostic) devices and reagens ivdd ivdr (in vitro diagnostic regulations) j-std-001 japan japan - ministry of health labour and welfare job descriptions job openings jobs (general) key performance indicators (kpi) korea kpi data labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) laboratory scope language requirements lead auditor course leadership leakage current leak tester lean legacy products legal requirements level of concern (fda term) life cycle of a device or product lithium ion batteries lot numbering low voltage directive 2006/95/ec machine shop machining processes maintenance malaysia management management representative management review management systems integration manuals (misc) manufacturing (general term) manufacturing location change manufacturing processes manufacturing site marketing (general) material testing and test reports mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdr (medical device regulations) mdr (medical device reporting) mdr 745/2017 mds (material declaration sheet) mdsap (medical device single audit program) mds reporting measureables (also see metrics) measurement (general) measurement and monitoring and test devices measurement equipment resolution and tolerances measurement systems measurement techniques and procedures measurement traceability measurement uncertainty (mu) medaccred industry program meddev - ec guidelines on medical devices medical device accessories medical device company or industry medical device electronics and electrical equipment medical device file medical device licensing medical device listing codes and classifications medical device parts and components medical device registration medical device repair and servicing medical device reports including incident reporting medical devices medical devices (disposable) medical device safety medical device software medical device standards and regulations medical equipment (general) medical software metal forming and stamping method validation metrics (measurables such as for objectives) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software minimum requirements minitab (statistical analysis software) mmc (maximum material condition - gd&t) monitoring monitoring and measurement mop (means of protection) mopp (means of patient protection) mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study multiple business units multiple national or international locations multiple sites multiple standards in a company music nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 navistar ndt (non-destructive test) new processes news nist (nat'l institute of standards & technology) non-normal data distribution non-sterile medical devices nonconformance report (ncr) nonconformances nonconformance system nonconforming material product or service notified bodies medical devices (nb-med) notified body nrtl (nationally recognized testing laboratories) oasis (online aerospace supplier information system) oasis database objective evidence objectives (quality environmental and other measureables) obl (own brand labeling) occupational health and safety (oh&s) occurrence ranking (fmea) oem (original equipment manufacturer) off the shelf (ots) equipment or parts or software ohsas 18000 & 18001 & 18002 ojt - on the job training (also see training) online internet training courses and universities operational control operational qualification (oq) operator error opportunities (general) opportunities for improvement (ofi) optical comparators order processing organization organizational knowledge organization structure orthopedic implants otc (over the counter) pharmaceuticals outputs (general) outsourced products and processes outsourced software ovens packaging (general) packaging labeling and related requirements packaging sealing packaging standards and specifications paper documents and records pcb (printed circuit board) pdca cycle (plan do check act) pear (process effectiveness assessment report) pems (programmable electrical medical system) performance evaluation studies (medical devices) performance measureables performance qualification (pq) personal health information personnel (also see employees and human resources) pfmea (process fmea) pharmaceuticals and pharmaceutical industry pin gages plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) pmda (japan) policies and policy statements policy documents post market activities (misc) post market clinical follow up post market surveillance ppap (production part approval process) ppk (related to process performance) pre-clinical studies (medical devices) premarket approval premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) privacy private label manufacturer private label products problem solving procedure examples procedure format procedure pack (medical devices) procedures (general) process audits process capability process changes and change notifications process controls and control plans process design and development processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process performance process validation process verification and validation product audits product code production production line production processes product limits product realization product safety products and services professional certifications and degrees profile of a surface project management proprietary information prototypes and prototype testing pull test purchase orders purchasing purchasing controls purchasing requirements qms (quality management system) qualification (product) qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality management systems quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quality systems quality tools quotes (quotations for a service or product) raps (regulatory affairs professionals society) raw materials raw material suppliers reach (ec 1907/2006) reach certification reach rohs recalls (general) receiving inspection recertification (to a standard) record retention requirements records (evidence) and records control reference standards refurbishing registrar audits registrar ratings and reviews registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard registration to multiple standards regression analysis (statistical technique) regulations and regulatory requirements regulatory affairs (ra) regulatory bodies regulatory compliance regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing remote locations and sites repackaging repair and or overhaul reproducibility (gage r&r) required documents required procedures required processes requirements and specifications research and development (r&d) research thesis research use only (ruo) device or software reselling resistance (electrical) resources response time responsibilities returned products and/or parts reusable medical devices revalidation of a process or product revision control revisions to a document or standard rework rework and repair procedures ring gage risk and opportunities risk based compliance risk based thinking (rbt) risk management and analysis risk management file (rmf) risk register robotics rohs (restriction of hazardous substances) root cause failure analysis rubber part or material russia s-charts safety (general) safety requirements and regulations salt spray testing samples (of a part product or service) samples and sampling plans sample selection (selection of samples) sample size sampling plans for attribute data sanctioned interpretations sap erp (enterprise resource planning) saudi arabia scales and balances scope (general term) scope of accreditation scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit self declaration sequence and interactions of processes service calls service company or industry service providers service provisions shelf life signatures significant digits (measurement) single use devices (sud) six sigma (general) six sigma green belt small companies (small businesses) software (general topics) software (off the shelf) software development life cycle (sdlc) software medical devices software tools (for qa statistics doc control etc.) software validation soldering sole source supplier sop (standard operating procedure) spain spare parts spc (statistical process control) special characteristics special processes specifications (general term) sri lanka stability testing stainless steel stakeholders in a company stamps (e.g. inked document control stamps) standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) startup business statistical analysis and studies statistical analysis tools statutory requirements sted (summary technical documents) steel plating sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage (general) strategic planning and objectives student questions sub-supplier substantial equivalence supplier supplier audits supplier control and monitoring supplier corrective & preventive action supplier development supplier evaluation/rating/approval supplier nonconformances supplier performance supplier quality supplier quality engineer (sqe) supplier requirements suppliers (general topics) supplier selection qualification and approval support processes surface roughness surgical products surveillance audits surveys (general) sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices symbols (general) taguchi designs and analysis tape measure targets (aka objectives) technical documentation technical files for medical devices temperature gages and probes templates tensile strength and tensile strength testing terminology test equipment testing (general testing topics) testing laboratories test methods and procedures and plans test reports texas tga (therapeutic goods administration) thickness (specification or measurement of) third party audits and auditing thread plug gages and set plugs thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) tolerances (dimensional or other units) top management torque wrench or tool toyota tpm - total productive maintenance tqm (total quality management) traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products training (general) training (on-the-job) training effectiveness training materials training plan and training matrix training records training requirements training sources and resources transition (between standards or revisions to a standard) transition audits transition period translations (languages) true position ts 16949 - automotive quality system standard turtle diagrams tus (temperature uniformity survey) uae (united arab emirates) ultrasonic testing uncertainty (aka mu - related to calibration) uncertainty budget (measurement) unique device identification (udi) united kingdom (uk) upper management upper management commitment usp (united states pharmacopeia) validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing value stream mapping (vsm) variables data vda 6.3 - process audit vda standards verification (general) verification of calibration verification testing version changes and change control virtual manufacturing vision measurement systems (electronic) visual inspection volkswagen want to buy waste (general) water (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding wire wire harnesses work environment work instructions (wi) x-bar charts zero defects

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