Medical Device Quality Certification
ISO 13485 Quality Certification is required for medical device companies as a qualification to market medical devices in most non-US markets.
Like all quality standards, ISO 13485 requirements can, if implemented incorrectly, create unnecessary inefficiencies and costs. MethodSense’s experience ensures your adoption of ISO 13485 leverages your current FDA compliance efforts or is implemented in the most practical way possible.
If you are a Contract Manufacturing Organization (CMO) working with or planning to work with the Medical Device industry, ISO 13485 Certification or implementing ISO 13485 compliant processes can give you a competitive advantage. Medical Device companies actively seek out partners that understand and support their compliance needs, and we can help you get there.
MethodSense’s successful ISO 13485 implementations led to Quality Certification and:
- Improved operational efficiency
- Reduced audits
- Enhanced marketing efforts
- Promoted international trade
- Met increased demand from customers
- Improved internal management of QMS