Consultancy and advice

RSQA will provide consultancy and advice on a wide range of topics including, but not limited to:

• European Harmonised Standards, including the EN ISO 9001, and ISO 13485 Standards series; together with their supporting Guidance Standards.
• The new ISO 9000: 2000 series of Standards (ISO 9001: 2000 and ISO 9004: 2000) .
• Medical Devices Directives (Active Implantable. Medical Devices, and In Vitro Diagnostics);
• Medical Devices Regulations;
• FDA cGMP;
• Preparation for EU Notified body audit;
• Preparation for FDA inspection;
• Preparation of FDA 510(k) submissions.
• We have extensive experience of installing ISO 9000 Quality Systems, especially for medical device manufacturers (ISO 13485 series), and offer help and advice to manufacturers embarking on such installation for the first time, or where subsequent certification audit has disclosed system deficiencies requiring corrective action.
• RSQA is especially strong in the sterile device sector and can advise on all aspects related to medical device microbiology including sterilization technologies. Our consultants have a wealth of expertise in the practical application of Ethylene Oxide, Moist Heat, Dry Heat and Gamma and Electron Beam Irradiation, and the appropriate European / ISO Standards. We can also advise on meeting regulatory requirements where novel sterilization methods are to be used.
• The interface between medicinal products and medical devices.

As an adjunct to our consultancy services we also conduct training courses from time to time. See our Training page for more information.

Further information

For further information please email us or call us on +44 (0) 207 936 9412.