Configurable/Custom made or accessories?

#1
Dear Elsmar users,

I am working on Configurable medical devices.

These devices are postural support chairs which are assessed by occupational therapists, this means the base chair is build up to order with a wide variety of add ons.

Im looking for some advice on the best conformity assessment route for these.
Do we think that these devices could be considered "Custom made"?
Should each add on be considered a Medical Device in its own right as an accessory?
Or should the device be covered as one technical file with optional extras some how?

Any advice would be appreciated, I cant get my head round how to cover this type of product from a technical documentation perspective.

Thanks
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
P GR&R (Gage R&R) Across Multiple Configurable Test Systems Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
V Configuration Management - Configurable, Managed and Controlled Document Control Systems, Procedures, Forms and Templates 3
A 4.3 Contract Review - Configured Product - Configurable subassembly Contract Review Process 5
J Gauge Suggestion: Specialty or Custom General Measurement Device and Calibration Topics 1
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
J Custom made medical devices - Wheelchairs EU Medical Device Regulations 6
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
M Informational ANVISA regulation for personalized/custom medical devices – RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 Medical Device and FDA Regulations and Standards News 0
M Custom Medical Device For Clinical Study Other Medical Device Regulations World-Wide 1
B Sterilization of a custom medical device Other Medical Device and Orthopedic Related Topics 1
D Medical device development - Custom test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
C If it's not a custom-made medical device... What is it? Clinician requests EU Medical Device Regulations 11
G Reporting measurement uncertainty for custom items Measurement Uncertainty (MU) 2
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
T Requirements and standards for medical custom Electrical Connectors EU Medical Device Regulations 2
W Product or Service? Custom Engineered Capital Equipment Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
J ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K DoC (Declaration of Conformity) for Custom Made Medical Devices EU Medical Device Regulations 1
B IEC 60825-1 Class 3R Laser Off-The-Shelf or Custom Label Needed Other ISO and International Standards and European Regulations 3
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
W Process Validation Training - Custom made Medical Device Design and Development of Products and Processes 4
D CE Marking for Custom Ordered Products Outside of the EU EU Medical Device Regulations 1
Q Process Control in High Volume Custom Electrical Enclosures Environment Statistical Analysis Tools, Techniques and SPC 4
V EO Sterilization of Drugs in Custom Convenience Kits Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
P Calibration of Custom Molds General Measurement Device and Calibration Topics 26
N Best Custom Software (To Track QMS & Processes) Provider Quality Assurance and Compliance Software Tools and Solutions 9
M Custom-Made Medical Device Regulations and Registration in Argentina Other Medical Device Regulations World-Wide 5
Fender1 Controlling Documents and Records in a Custom Weld/Fabrication Company Document Control Systems, Procedures, Forms and Templates 10
C Custom Device Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Enclosure Flammability Rating of Molded-In Custom Color Liquid Concentrates IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J 3 Level Custom DOE in Minitab Using Minitab Software 3
J Custom Tools as SOUP? (Software of Unknown Provenance) IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Using a Custom Process FMEA (PFMEA) Form FMEA and Control Plans 4
K Does ISO 22000 make sense for a Custom Injection Molder? Food Safety - ISO 22000, HACCP (21 CFR 120) 7
L Validation and documentation activities required for a custom-made software Qualification and Validation (including 21 CFR Part 11) 2
S Design Review: Can I exclude Custom Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
QMMike Surveys - Customer, Supplier, Custom... ect.... Quality Tools, Improvement and Analysis 1
R Custom DOE (Design of Experiments) Analysis in JMP Quality Tools, Improvement and Analysis 11
J Tailor-made or Custom Made Device? EU Medical Device Regulations 1
DanteCaspian Operator Break Coverage - Custom injection mould shop Manufacturing and Related Processes 9
DanteCaspian Dry Erase: Custom documents with laminate sheets Lean in Manufacturing and Service Industries 7
V Custom prototype checklist for Europe and FDA ISO 13485:2016 - Medical Device Quality Management Systems 1
M Calibration of Custom 6061 T6 Aluminum or Delrin Plastic Setup Tools?? General Measurement Device and Calibration Topics 5

Similar threads

Top Bottom