SERVICES

Regulatory Consultancy

Regulatory Gap Analysis
MDD and IVDD
MDR and IVDR
MDD to MDR Transition
CE Marking

Quality Consultancy

All medical device manufacturers who are marketing and selling their products within the EU, need to maintain the controls for the product lifecycle.
 

ISO Certification & Management

ISO9001 Quality
ISO13485 Medical Device
ISO14971 Medical Device
ISO14001Environmental

Remediation

Design History File review
Complaint files
Device Reporting
Notified body non-conformity report

Project Management

Our extensive experience enables us to maximise value for you by ensuring the projects are initiated right and managed in line with the industry.

Information Security

Organization of Information Security
Human Resource Security
Asset Management
Access Control

GDPR

We work with you to discover how GDPR will impact your business. We therefore help you begin the journey of learning.
 

Business Continuity

Training needs analysis
Competency matrix
Continuity Management System
Audit program
Continuous improvement

Business Analysis

Requirement gathering
Review Technical Documentation
Performing Technical research
Performing Industry and competitive analysis