Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions?

Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#5
I suggest you contact the FDA directly, as described in the classification pathway guidance document. You won't find the answer to your question here.
 
Thread starter Similar threads Forum Replies Date
adir88 Tools for Normal and Fault Conditions ISO 14971 - Medical Device Risk Management 9
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
F How do you add accuracies for tools with different measurement devices? General Measurement Device and Calibration Topics 1
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
K PCI DSS - MS Paint and other screenshot tools Other ISO and International Standards and European Regulations 0
DuncanGibbons Are there aerospace standards for the development and manufacture of euipment and tools? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
G ISO 9001 and ISO 17025 - Measuring tools not in calibration system General Measurement Device and Calibration Topics 3
S Tools and equipment provided by customer - Considered as external provider? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S I have just purchased the all new Core Tools Software (CTS) from AIAG IATF 16949 - Automotive Quality Systems Standard 37
M Informational FDA Qualifies First Biomarker Test as Part of Medical Device Development Tools (MDDT) Program Medical Device and FDA Regulations and Standards News 0
A Statistic Tools to Know Capability of Sealing Machine for Seal Width Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Interesting Discussion Surface Cleanliness Real Time Test Tools General Measurement Device and Calibration Topics 2
R Unsecured pedestal mounted tools, oh my! Human Factors and Ergonomics in Engineering 11
H Evaluate Contingency Plan for Equipment and Tools IATF 16949 - Automotive Quality Systems Standard 4
I Tool maintenance and calibration procedure - Calibrating tools/equipment AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
O Storage of Calibrated Tools General Measurement Device and Calibration Topics 12
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
L Radius Measuring Tools General Measurement Device and Calibration Topics 4
Q Analyzing Process Bottlenecks Tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Y Differences between the Classic 7 QC Tools and New QC Tools Quality Tools, Improvement and Analysis 3
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Tools for Risk - ISO 9001:2015 - Suggestions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Pneumatic & Electrical Torque Tool - Calibration/Verification of 'Power Tools' General Measurement Device and Calibration Topics 2
B Kaizen Event - Which tools to use? Lean in Manufacturing and Service Industries 8
I What are considered next generation ITSM tools? IT (Information Technology) Service Management 1
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
R Cleaning validation for Molding Tools? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G FRACAS Tools Problem Solving, Root Cause Fault and Failure Analysis 1
A What are methods and tools to measure Workload analysis ? Human Factors and Ergonomics in Engineering 1
P IT tools for Knowledge Sharing in a large Organization Misc. Quality Assurance and Business Systems Related Topics 1
T Tools Six Sigma for my Automated Machine Six Sigma 8
O Lean Tools in Labour Intensive Manual Manufacturing Lean in Manufacturing and Service Industries 20
D Contact Retention Tools Question General Measurement Device and Calibration Topics 3
E Methods in Measuring Angles or Checking Angles for tools? General Measurement Device and Calibration Topics 10
A Calibration of Non-Measurement Tools (e.g.: Hydraulic Jacks) Capability, Accuracy and Stability - Processes, Machines, etc. 5
sagai New Draft Guidance for Medical Device Development Tools Other US Medical Device Regulations 3
D 21 CFR 11 Tools Validation - Electronic Document and Records Control Qualification and Validation (including 21 CFR Part 11) 5
L Requirements for employees personal precision measuring tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Production Planning Templates, Tools & Techniques Document Control Systems, Procedures, Forms and Templates 1
T What tools are there to monitor a Manufacturing Process or Operation? Quality Tools, Improvement and Analysis 2
T Relationship between TS16949 and 5 Core Tools & relationship between 5 Core Tools IATF 16949 - Automotive Quality Systems Standard 5
J RoHS/REACH Compliance Tools and PLM Integration RoHS, REACH, ELV, IMDS and Restricted Substances 14
B Frequently asked PPAP, FMEA, SPC, MSA, APQP & 7QC Tools questions for Interviews Career and Occupation Discussions 1
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T What Problem Solving Tools do you use the most? Problem Solving, Root Cause Fault and Failure Analysis 4
quality1 Tools for Work Instructions Distribution to Assembly Lines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Any experience/feedback on statistical software tools...minitab -design expert -JMP Using Minitab Software 4
M TS 16949 8.1.1 Identification of Statistical Tools - Requirement Scope? IATF 16949 - Automotive Quality Systems Standard 13
S Benefits of the use of Audit Guidance Tools during the Audit Process Internal Auditing 5
Similar threads


















































Top Bottom