medlaQ | Consulting for medical devices

Consulting medical products

medlaq Beratung Medizinprodukte


Medical devices are developed, manufactured and distributed in a highly regulated legal environment. Whereas international regulations are similar, there are regional differences in terms of details you need to take into consideration.
The risk classification of a medical device may also be different in the various target markets.
The regulatory requirements include the following:
  • Establishment, maintenance and improvement of your company’s Quality Management System 
  • Technical Documentation of the design, manufacturing and quality control of your medical device
  • Documentation of the performed Clinical Studies
  • Technical Documentation of the post market surveillance activities of your company: Vigilance and Post Market Clinical Follow-up Studies

By applying harmonized standards, you can show that your medical device complies with the relevant safety and performance requirements.

Your need to pay particular attention to the oft-neglected downstream processes of transport, storage, updating, servicing, maintenance, repair, decommissioning and disposal processes for your medical device in development and production.

It is vital to be familiar with all necessary and applicable regulatory requirements of your medical device early in the development phase. One of your most important tasks is to define your target markets and the corresponding registration or approval strategy.

In my professional life I have gathered detailed theoretical and practical knowledge and experience in regard to the lifecycle of medical devices. I would be happy to share my knowledge with you in order to bring your medical device successfully to market.

medlaQ - Consulting for medical devices

Dr. Bernhard Gerstenecker

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