Product Quality is enhanced by working in a systematic manner to formalised procedures designed to eliminate the occurrence of deficiencies and non-conformances.
It is the responsibility of manufacturers to compile, implement and integrate the requirements of such procedures into their regular working routines and to ensure that all such methods are clearly designed, defined and documented.
RSQA Ltd have assisted many manufacturing companies with writing their QA Manual and with their Procedures Manual, the means of implementing the requirements of the QA Manual. We also advise upon and provide the record forms necessary to comply with the Statutory Requirements contained in the Medical Device Directive 93/42/EEC as from time-to-time amended.
We provide the knowledge and experience to overcome problems encountered within existing systems; troubleshooting etc where external auditors have raised non-compliances against such systems.
RSQA have long experience of the above matters and provide training courses in-house on the requirements of the Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC. See Training page for more information.Post marketing surveillance, complaints, and vigilance reports.
For further information please email us or call us on +44 (0) 207 936 9412.