Our Services

At Medalps, we support manufacturers in meeting the clinical evidence requirements of Regulation (EU) 2017/745 (MDR) through high-quality, fully compliant clinical evaluations.

At Medalps, we help medical device manufacturers establish and maintain compliant, efficient, and pragmatic ISO 13485 Quality Management Systems.

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Medalps provides dedicated PRRC services to help you meet the Swiss requirements and access the market with confidence.

We manage the entire biological evaluation process in accordance with the ISO 10993 series — from defining the strategy (BEP) to compiling the final Biological Evaluation Report (BER).

We support medical device manufacturers in building and maintaining robust Risk Management systems aligned with EN ISO 14971 and the EU MDR (2017/745).