Helping you to achieve global success
As an experienced consultant and service provider, Schrack & Partner can help you to register your company and create authorisation documentation. In addition, we can ensure that your quality management system is compliant with legal requirements around the world.
Registration and authorisation outside the EU
For German medical device manufacturers, markets such as the USA, Canada, Argentina, Brazil, Mexico, Colombia, Japan and Australia are becoming more and more interesting. Quick market access is often the key to achieving success in these countries. This requires a professional approach to registration and authorisation, as well as the creation of any required documentation.
Typical projects in which you can benefit from Schrack & Partner's support include expanding QM systems to include country-specific requirements, and creating authorisation and registration documentation.
Do you require support when creating authorisation documentation?
In coordination with your partner and distributor on site, we can create country-specific authorisation documentation for you based on your existing device documentation. If necessary, we can analyse the product requirements in advance and work together with your development team to expand your verification and validation plan. This ensures that all country-specific requirements are met and that the required documentation is available in good time. Our team is able to create documentation in German and English.
How can you implement country-specific requirements in your QM system? Are you ready for an audit by the corresponding authority or certification body?
We work closely with you to expand the processes in your QM system. On request, we can use realistic simulations or "mock audits" to ensure that you are ready for auditing by authorities and certification bodies in your target markets.
Registration and applications
We can take on the task of registering your company and maintaining product information in the relevant databases, provided that this can be done in English.
Registration with the US FDA as an established standard is one of the services we offer.