regenold swiss

Introducing regenold swiss AG, the newest addition to the regenold group: your partner for development, regulatory and market access for healthcare products in Switzerland.

JensonR+ is part of the regenold group, offering a full suite of regulatory services from development to market access and life cycle management.
The newest addition to the group is regenold swiss AG, which offers regulatory services and consultancy to medical device and pharmaceutical companies from Switzerland or foreign companies intending to enter the Swiss market.

Services include:

  • Support across the whole product life cycle from product development strategies to post-market surveillance
  • Specialised medical device expertise, e.g. for biological evaluation, clinical evaluation or compilation of technical documentation
  • Particular focus on borderline products (medicinal products / medical devices / cosmetic products) and combination products (medical device + medicinal product)
  • Proven track record with software as medical device
  • QMS support for GMP / GDP or ISO 13485 / MDR compliance
  • Auditing services

regenold swiss can take over local legal responsibilities for the Swiss market, temporarily or permanently, and can act as your contact with Swiss authorities.

Within medical device regulations, Switzerland and the UK are now considered third countries outside the EU MDR. Specific regulations for CH and UK apply and local representatives are required.

regenold swiss AG offers the role of Swiss Authorised Representative for Medical Devices (CH-REP) for manufacturers outside Switzerland.

regenold swiss
regenold swiss

regenold swiss can help clients maximize the value of their product or device’s life cycle amid a constantly evolving regulatory and market access environment.

Like JensonR+, they are also a member of regulanet® which is a network of independent regulatory consultancies and experts with representation in over 90 countries throughout the world.

regenold swiss is also a member of Swiss Medtech.

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