Regulatory Affairs.
Benefit from our experience.

We accompany the process from a validated prototype to an approved medical device.
Our services include design transfer consulting for both small companies new to the medical device market and global players with a long product history. We specialize in Class IIa, IIb and III devices with stringent design and document control requirements. Our focus is on complex technical devices where we assist our customers to convert a prototype into serial production. Our specialists have application-specific knowledge in various areas of medical technology and in vitro diagnostics, so we are familiar with the design of technical documentation and design dossiers in these areas.

Design transfer and product launch

Consulting, concept development and implementation for series production and the first marketing of new products according to MDD/MDR and 21 CFR 820.

Quality and risk management

We ensure that medical devices comply with current legal requirements and that a safe risk management is established.

Market observation and post market surveillance

Consulting and development of a proactive and systematic process for a monitoring of medical devices after they have been placed on the market.

Our service is based on experience and competence.

  • Quality management according to ISO 13485

  • Creation of documents (DHF, DMR) according to CE and FDA requirements

  • CE-conformity declaration

  • Supervision of the CB type testing

  • Know-how about current approval topics

  • Establishment of risk management files in accordance with ISO 14971

  • Comprehensive knowledge of standards and guidelines for medical technology

  • Product adaption to changed regulatory requirements

  • Know-how about current approval topics

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