MDSAP is an audit scheme based on ISO 13485 that integrates country-specific regulatory requirements into quality management.
The major advantage for medical device manufacturers: With a single, integrated ISO 13485 | MDSAP audit, compliance with standards and regulations for various international medical device markets is assessed.
The audits are carried out by us together with TÜV Süd Product Service.
We are happy to support you!
Call us at: +43 1 8863491 or email us: office@encotec.at.
Our offer: MDSAP upgrade
Guidance and support in all phases of the MDSAP upgrade
- Assessment & project planning
- Implementation and training
- Internal audit & certification
We have specialized expertise when it comes to integrating quality management requirements with international regulatory requirements relevant to medical device approval—for example, Health Canada and the FDA.
Are you planning an MDSAP upgrade?
We are happy to help you!
——————————————————————————————————————————————————————
Call us at: +43 1 8863491 or email us: office@encotec.at.
