PathwayGen's Journey to UKCA Marking with Apotech
Introduction
PathwayGen
In response to the UK's new post-Brexit regulatory requirements, PathwayGen, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products.
Types
- Regulatory Strategy
- UKCA Compliance Support
Scope of work
Apotech provided end-to-end support for UKCA compliance, including regulatory gap analysis, documentation review, conformity assessment facilitation, and label adaptation to meet the UKCA marking requirements.
Key numbers
Team
6 compliance experts
Location
UK
Length
8 months
Type
UKCA Marking Compliance
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