Risk Management and Design Controls

Medical Device Risk Management and Design Controls: Issues Device Manufacturers Need to Know

Medical device design and expansion processes in the context of risk management need careful inspection and planning by manufacturers. We inspect five key issues companies face when connecting design and development with risk management and, essentially, patient safety.

Risk/Benefit analysis is required in clause 6.5 of ISO 14971, but there is very little guidance on what is expected.  How do risk/benefit analyses impact design controls? 

Risk/benefit survey are very much device-specific and situation-dependent.  Mostly, it is expected that the clinical data on benefits and risks display position for all medical states and target populations enclose by the intended purpose as differentiated to the current state of the art. Therefore, the present knowledge/state of the art needs to be recognized; that is, manufacturers should identify applicable (similar) standard devices and medical options available to the target population.  

Product risk management is owned by the manufacturers, but how can service providers (e.g. software developers) contribute to safe design?

Initially, it must be understood that any element outsourced by an end-equipment manufacturer nevertheless remains their authority.  That is, likewise with the FDA QSR 820.50, and ISO 13485 Clause 7.4, end-equipment manufacturers are eventually responsible for their product, including where product elements, such as software, are outsourced. That said, suppliers may display their dedication to providing a high level of honour through compliance with ISO 13485.  Note that one of the changes established in ISO 13485:2016 was the allocation that suppliers or other external parties providing the product to organizations can also select to observe with the standard. 

Read More  - Risk Management and Design Controls

Contact details –

Phone no -  9325283428

Mail  - dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device