Besides offering ISO 13485 compliant production, we can assist you throughout your entire product development and design process, in compliance with the MDR regulation. If needed, you can also outsource the entire documentation of your medical device to us. To make sure we can fulfil your every need, Teampac’s in-house specialists are supported by a broad network of external professionals.
We are fully familiar with what the replacement of the Medical Device Directive by the MDR regulation means in practice. To kick start your project, we can go through the ”General Safety and Performance Requirements” checklist. This is complemented by our comprehensive risk management file, which covers all the MDR and ISO 14971 requirements. What’s more, we can help you with clinical evaluation and risk assessment. When necessary we also handle pilot production, validation, and accelerated shelf-life testing. Finally, we gather the documentation into a comprehensive technical file.
Our services during your product’s lifecycle include periodic risk assessment reviews and risk management updates and change control management.
Anything you’d like to ask? We’re happy to help. Reach us on +358 (0)19 521 1800.