About
Enthusiastic, client oriented, expert consultancy supporting medical device, pharmaceutical and regulatory organisations with quality, regulatory and clinical needs. With over 17 years experience in the medical device industry we offer consulting, training and auditing services to support companies in the medical industry to meet regulatory requirements, implement best practice and to improve quality/business. In addition, services are offered to Notified Bodies as a Lead Auditor, Technical Reviewer and Sterilisation Expert.
Technologies
Outlook
Microsoft Office 365
Mobile Friendly
Nginx
Facebook Widget
Facebook Login (Connect)
Bootstrap Framework
Keywords
auditing
sterilisation
quality management systems incl iso13485 iso9001
regulatory affairs for medical devices
problem solving
training
quality management systems incl iso13485 ampiso9001
medical equipment manufacturing
device safety risk assessment
risk management systems
pharmaceuticals
healthcare
regulatory approval
regulatory problem solving
biological safety assessment
medical device consultancy
regulatory compliance support
biocompatibility testing support
product lifecycle support
regulatory documentation review
regulatory training
device safety evaluation
post-market surveillance
device classification assistance
regulatory strategy development
sterilisation process validation
consulting
regulatory gap analysis
regulatory documentation
biocompatibility
Company Information
-
Employees 1
-
Founded 2011
Location
8 Broad Street, Ottery Saint Mary, England, United Kingdom, EX11 1BZ
