ISO 13485 Consultant | Certification - Operon Strategist

As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of ISO 13485 Certification for their organization.

ISO 13485 Certification

Quality Management System for Medical Device Industries

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ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes which is an ISO standard, it was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. ISO 13485 standard replaces earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published standard was ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

ISO 13485 Standard Benefits

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• Increase access to more markets worldwide with certification.
• Outline how to review and improve processes across your organization.
• Increase efficiency, cut costs and monitor supply chain performance.
• Demonstrate that you produce safer and more effective medical devices.
• Meet regulatory requirements and customer expectations.

Requirements of ISO 13485 2016

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Requirements of ISO 13485 2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Operon Strategist is ISO 13485 consultant helps to create the documents for ISO 13485 certification. In the first phase. Our special screen sharing module helps you create that documentation and provide adequate training. This includes the creation of the SOP,s work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the second phase, we provide assistance to implement the system at Shop Floor and provide the need-based training to make sure that the system is adequately implemented. On a routine basis, we monitor the system including the Management review meetings, Internal quality audits, Customer Complaints, CAPA Management, Handling of Non-confirming Products etc. We assist to maintain the complaint system and continual preparedness for the audits.

Read More  - ISO 13485 consultan

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3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@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  

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