IMG_20180820_145052~4 Mesh UK CT Email Joanne

QUALITY ASSURANCE

 

Quality managementsystems design and implementation

 

QMS audits and ISO certification

 

13485, 9001, 14971, 60601, 10993, (EU) 2017/745, 3071/746 CFR 820, CMDR

 

Production and process validation

 

Systems & software validation

 

Risk management

 

REGULATORY AFFAIRS

 

Regulatory strategies relating to regulatory compliance and key market submissions

 

Marketing applications for all classes of  devices (apart from active implantables) for Europe, Canada, US, Russia and UAE Tenders

 

CE marking for all classes of medical devices

 

EXPERT WITNESS

 

Technical reports, analysis and fact based opinion in the field of medical devices design, manufacture and regulation

 

 

 

Please contact:Joanne by email - e[email protected]