RSQA Ltd. is a unique consultancy, training and regulatory resource company established in 1995 to meet the specific needs of the international medical device industry and regulatory communities. A subsidiary company, Russell Square Quality Representatives Ltd. (RSQR) provides an Authorized Representative service.
Consultancy and assistance can be provided on harmonized standards, especially ISO 9001: 2008 and ISO 13485, the Medical Devices Directives, and Medical Device Regulations.
RSQA provides training courses in all aspects of European Medical Devices Regulatory issues. We provide specialist training on Sterilization, Process Validation, Microbiological control, and all three European Medical Devices Directives. We can also deliver training on Quality Systems and FDA cGMP requirements. Our training courses are flexible, modular, and may be provided anywhere by arrangement.
RSQA undertakes Internal and third party audits against device harmonized standards / Medical Devices Directives / ISO 9001 /ISO 13485 of medical devices company Quality Management Systems, using our own IRCA-registered and CMDCAS-qualified International Lead Assessors. Full and detailed reports are presented according to client / regulatory requirements.
RSQA will prepare Technical Files from clients' data in compliance with European regulatory requirements. Our product specialists and technical experts are available to review company Technical Files and Design Dossiers.
RSQA will assist with the construction and installation of documented Quality Management Systems, including Vigilance and Complaints requirements, and Labelling and Instructions for Use. We have extensive experience of Own Brand Labellers' requirements.
For manufacturers of all Classes of medical device, RSQA can provide a complete custom-built package which embraces a fully documented Quality Management System conforming to the requirements of ISO 9001: 2008 and ISO 13485, the Medical Devices Directive 93/42/EEC, in its latest amendment, and relevant product Harmonized Standards.
For manufacturers outside the EEA, Russell Square Quality Representatives Ltd. (RSQR) provides a complete and professional authorized representative service in full compliance with the European Medical Devices Directives. RSQR is a subsidiary company of RSQA.
All RSQA's key personnel were formerly employees of the Medical Devices Agency - the UK Competent Authority under the Medical Devices Directive 93/42/EEC, and part of the UK Department of Health. Their various former roles within that Agency make them uniquely qualified to advise upon UK and European medical devices matters.