image (3)

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
Frame 1000005946

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

Management

Team

6 compliance experts

Charity

Location

UK

Combo Chart

Length

8 months

WeChat

Type

UKCA Marking Compliance

Excited to work together on your next project?

Global in-country regulatory support 
510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range f...
Find out more
Global in-country regulatory support 
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innova...
Find out more
QMS Implementation for Class III Medical Device
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was lo...
Find out more
Breakthrough Program
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharma...
Find out more
Regulatory Strategy  IVDR / FDA
EU-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the ...
Find out more
EU-IVDR Technical File Remediation
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regula...
Find out more
Software as a medical device (SaMD)
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive card...
Find out more
Process and Test Method Validation Review and Improvement
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with h...
Find out more
Quarterly Internal Audits
Prosthesis manufacturer
Prosthesis manufacturer Introduction Global API Manufacturer As part of their international development strategy, our client wanted to get MDSAP certified with ...
Find out more
Prosthesis manufacturer
Streamlining ISO 13485 Certification for a connected medical device
Streamlining ISO 13485 Certification for a connected medical device Introduction Our client is a startup at the forefront of connected health technology (diabet...
Find out more
Streamlining ISO 13485 Certification for a connected medical device

Previous

Next

Contact us today to find out how we can support you in your next project.

Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.