In the dynamic and highly regulated world of medical technology, compliance with legal requirements is a key component for patient safety and the associated market success of your product. With our comprehensive services in the field of regulatory affairs, we are at your side as a competent partner and support you in getting your products authorised efficiently and in compliance with regulations in a wide range of countries.
Our Focus in the Area of Regulatory Affairs
- Authorisation strategies and communication with authorities:
We develop customised approval strategies to guide your products smoothly through the approval process. - Technical documentation:
Our experts create and review your technical documentation in accordance with the requirements of the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and other relevant guidelines. - Clinical evaluations:
We support you in creating and updating clinical evaluations and post-market surveillance to demonstrate and ensure the performance and safety of your products. - Labelling and UDI management:
We ensure that your product labelling and Unique Device Identifiers (UDI) comply with global regulations in a wide range of countries. - Regulatory due diligence:
For mergers, acquisitions or product takeovers, we are happy to provide support with analyses of technical documentation, QM systems or other issues relating to the regulatory aspects of your project.
Why Regulatory Affairs with invenio?
Our many years of experience in medical technology combine technical know-how with regulatory expertise. Whether it's the introduction of new products, the transition to the MDR/IVDR or compliance with industry-specific requirements – we are your reliable partner.
Your advantage:
With our support, you can reduce the effort and complexity of the authorisation process while ensuring the quality and compliance of your products. Together, we set new standards for your innovative strength and marketability.
Let us ensure the regulatory success of your medical devices – contact us for a personal consultation!
Your Expert for Regulatory Affairs in Medical Technology
Stephan Drozniak
Managing Director
invenio Healthcare Solutions GmbH
invenio Healthcare Solutions GmbH
Sossenheimer Weg 32
65824 Schwalbach am Taunus
Contact me
P +49 (40) 1806571-51
M +49 (178) 4571675
Would You like to contact us?
Gladly we are at your disposal for any questions!
