ISO 13485 : 2016 is the quality system standard specifically developed for medical device industry. ISO 13485 is a mandatory requirement for CE Marking. It is similar to US FDA Medical device GMP (21 CFR 820). If you are a medical device company in the USA or sending products to the USA, it is advisable to develop an integrated quality system complying with ISO 13485 and FDA GMP. Which will help to avoid the burden of keeping two separate quality system documents?
Selection of Certification Body
If you are a US Manufacturer exporting product to the Europe, selection of certification body is important. It is wise to choose a European notification body for ISO 13485 Certification, so you can save time and money with single audit. If you choose ISO 13485 Certification with one registrar (certification body) and choose a different notification body for CE Marking, you have to face 2 audits in a year.
Our experienced consultants can help you to develop and implement an integrated quality system for ISO 13485 and FDA 21 CFR 820. Our service includes.
- Quality manual
- Quality system procedure
- Quality system implementation
- Internal audit
- Certification body selection
- ISO 13485 audit support