Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020?
EU Medical Device Regulations 3
Jul 2, 2020
What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015?
Other Medical Device Related Standards 4
Jun 29, 2020
Turkish Requirements - Does the Software need to be translated?
CE Marking (Conformité Européene) / CB Scheme 2
Jun 22, 2020
Where does IATF 16949 address Process mapping?
IATF 16949 - Automotive Quality Systems Standard 3
Jun 16, 2020
Does Pakistan Medical Device Import License allows parallel import?
Other Medical Device Regulations World-Wide 0
Jun 15, 2020
Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001?
Process Maps, Process Mapping and Turtle Diagrams 35
May 21, 2020
Does anyone have a API Q1 Documentation Package?
Quality Management System (QMS) Manuals 1
Apr 30, 2020
What is our product classification? (Does Unclassified classification still exists)
Other US Medical Device Regulations 14
Apr 30, 2020
Does a CE mark infer meeting all applicable standards?
CE Marking (Conformité Européene) / CB Scheme 4
Apr 23, 2020
Small Company - Internal audit process - Who does the audit?
Internal Auditing 16
Mar 10, 2020
Does anyone have an excel IATF 16949 Internal Audit checklist I could use?
IATF 16949 - Automotive Quality Systems Standard 7
Mar 9, 2020
Does AS9100 require traceability to operators performing the work?
AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Mar 6, 2020
Does anybody use Detection in medical device Design FMEA?
ISO 14971 - Medical Device Risk Management 18
Feb 24, 2020
EN ISO 14971:2019 does not include the Annex Zs
ISO 14971 - Medical Device Risk Management 4
Feb 20, 2020
Does "Similar Device" = "Predicate"?
EU Medical Device Regulations 7
Feb 20, 2020
Document Control Stamps - Does anyone still stamp their documents?
Document Control Systems, Procedures, Forms and Templates 21
Feb 14, 2020
Does Solidworks (2D/3D drafting modules) need validation?
Other Medical Device and Orthopedic Related Topics 5
Feb 11, 2020
Definition Open Audit - What does an Open Audit mean?
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Feb 10, 2020
Does training have to be written?
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Feb 5, 2020
"IATF-Compliant" IATF 16949:2016 certification? What does this mean?
IATF 16949 - Automotive Quality Systems Standard 13
Jan 24, 2020
Why does Official Journal list superseded standards?
EU Medical Device Regulations 6
Jan 23, 2020
Record Management - Does the QMS need to control templates of records?
Records and Data - Quality, Legal and Other Evidence 17
Jan 22, 2020
QR Code Standard ISO/IEC 15417:2007 - Does anyone use it?
Other Medical Device Related Standards 3
Jan 8, 2020
Does any here use an internal auditing tool that works on different platforms?
Internal Auditing 3
Dec 27, 2019
IAQG SCMH explains "positive risk"..........but does it?
AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Dec 21, 2019
Where does "as far as possible" stop? FMEA - EN 14971
ISO 14971 - Medical Device Risk Management 29
Dec 18, 2019
Does anyone have an API Q2 checklist for internal auditing?
Oil and Gas Industry Standards and Regulations 1
Dec 10, 2019
Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item?
Measurement Uncertainty (MU) 10
Nov 28, 2019
External power supplies: How close does the safety report have to match the end-use application?
IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Nov 20, 2019
Does 820.30 include the manufacturing process?
21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Nov 19, 2019
Does ISO 13485 7.3 include the manufacturing process?
ISO 13485:2016 - Medical Device Quality Management Systems 14
Nov 19, 2019
When does the FDA consider a component a medical device?
21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
Nov 15, 2019
Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU?
Other Medical Device Related Standards 9
Oct 30, 2019
Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133)
Occupational Health & Safety Management Standards 2
Oct 22, 2019
Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500?
Manufacturing and Related Processes 0
Oct 15, 2019
Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing?
Quality Management System (QMS) Manuals 14
Oct 14, 2019
EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules?
EU Medical Device Regulations 2
Oct 14, 2019
Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered?
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Oct 9, 2019
How Often Does FDA State Consultant Recommended in a Pharma WL?
US Food and Drug Administration (FDA) 1
Oct 2, 2019
Does ITAR apply to Exporters only?
Other ISO and International Standards and European Regulations 6
Oct 1, 2019
Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed?
ISO 13485:2016 - Medical Device Quality Management Systems 1
Sep 25, 2019
What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site?
Other Medical Device Regulations World-Wide 3
Sep 13, 2019
Does Class 1 Medical Device need to be certified to MDSAP?
Canada Medical Device Regulations 5
Sep 6, 2019
Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices?
ISO 13485:2016 - Medical Device Quality Management Systems 3
Aug 28, 2019
Does an RMA = a Customer Complaint
Customer Complaints 4
Aug 23, 2019
Does cFDA accepts FDA approval or CE marking?
China Medical Device Regulations 1
Aug 20, 2019
Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1
Medical Device and FDA Regulations and Standards News 0
Aug 17, 2019
When does a Distributor become a Specification Developer?
21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Jun 28, 2019
Does Least-squares (LSQ) simulate perfect roundness?
Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Jun 19, 2019
Does the company violates any regulation/standard by selling device without warranty
ISO 13485:2016 - Medical Device Quality Management Systems 5
Jun 19, 2019