Pillans Group Consultancy

Following the UK leaving the EU in early 2020, medical device companies are required to provide deeper scrutiny, additional certification, and in-country representation requirements beyond EU, to market their devices in the UK.

As a UK based company, we can help you navigate post-Brexit compliance requirements in England, Wales and Scotland, and provide Regulatory Compliance & Management expertise for Medical Devices in the UK market.

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We have a strong working partnership with a UK Medical Distributor who has a strong presence within the NHS and private sector who are looking to develop their portfolio with new suppliers, in conjunction with our regulatory support. We can act as your UK Responsible Person (UK RP), your UK Medical Device Importer and your Person Responsible for Regulatory Compliance (PRRC).

Including

ISO 13485:2016, ISO 14001:2015, ISO 9001:2015 Implementation, Audit & Gap Analysis

All QMS requirements including: Supplier Management, Product Registration, Recalls & Adverse Event Management