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Quality and Regulatory Affairs

Quality and Compliance is at the core of Crest Medical’s business. Our credentials are a guarantee of product quality and safety, alongside independently recognised assurance for our customers that Crest Medical is a reliable, compliant and trusted partner.

Our in-house Quality Department has a dedicated resource, committed to ensuring that our extensive portfolio of CE marked products comply with all legal requirements of the Medical Devices Regulation in 2021. The team is committed to assisting our customers to ensure their needs are met, whilst continually developing new and existing product ranges and providing End-to-End Quality and Regulatory Support in global markets.

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Accreditations

Crest Medical holds a range of internationally recognised certifications, accreditations and licenses.
These marks of excellence, demonstrate our commitment to quality and compliance across our group's businesses.

ISO Logo

22716
ISO Certified Good Manufacturing Process
9001:2015
ISO Certified Quality Management

LSAS Logo

Labour Standards Assurance System Level 3

BHTA logo

British Healthcare Trades Association

SGS Logo

ISO 13485: 2016; ISO
(Directive 93/42/EEC)

FDA Logo

Food and Drug Administration
(Registered)

Future Quals Logos

Accredited Centre Delivering Ofqual
&
SQA Registered Courses

MHRA Logos

WDA (H) Wholesale Dealers Licence;
Manufacturer / Importer

CMC Logo

European Registered Office
CMC Medical Devices

Home Office Logo

Home office Drugs & Firearms Licensing
Home Office Controlled Drugs Licence,
schedules (2-5)

European Medicines Agency Logo

Good Distribution Practise (GDP)
&
GMP Compliance