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The Value of ISO 13485 in a Design Centric, Medical Product Development Firm

This article explores the value that ISO 13485 Certification brings to both the medical design and development firms that maintain certification and to the clients that benefit from them. Common misconceptions about a Certified QMS include that it adds expense to the project and that it is acceptable to put off quality controls to later phases when either the FDA Consultants or the CMS firm will take it on. This couldn’t be further from the truth. 
This article further dives into the differences between a compliant quality system and a certified one -  accountability. Without the need to be audited each year there is much less accountability. Key take homes of ISO 13645 include:
- The inclusion of Risk Management and Design Controls
- Creating a Design & Development plan
- Developing meaningful inputs
- Defining and Maintaining clear deliverables
- Creating documentation control and records management

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