GAMA Healthcare’s Regulatory Department is responsible for the regulatory approvals of Gama Healthcare products and systems including :
- Medical Devices Directive 93/42/EEC (as amended by 2007/47),
with CE certifications under Annex II and Annex VI of this Directive.
- Biocidal Products Directive (BPD) 98/8 and new Biocidal Products Regulations 2012 soon to supercede the BPD,
- Cosmetics Regulation 1223/2009
- Detergent Directive 648/2005 (as amended)
- REACH Regulation 2008 (as amended 2011)
- WEEE Directive 2012/19/EU
- EMC Directive 2004/108/EEC
In addition product quality and
systems registrations under:
- ISO 13485 2012 Medical Devices ‐ Quality management systems ‐ Requirements for Regulatory purposes.
- ISO 9001 2008 Requirements for Quality management systems.
Product compliance testing including:
- ISO 13704
- EN 14561, EN 14562 and EN 14563
- EN 1500
- EN 1276
Manufacturing and supplier site audits and approvals.
Phillip J Bates BSc, ACQI, AIEMA, CBiol.
Phillip Bates is the head of GAMA Healthcare’s Regulatory Affairs and Quality Assurance Department. He heads a very effective RA/QA group with global responsibilities. Phillip has qualifications in Microbiology and Biochemistry. He is also a Qualified Lead Auditor for several European Directives and ISO quality standards and has extensive knowledge of the Quality and Regulatory markets that Gama Healthcare deals in globally.
He was the main Medical Device Lead Auditor at BSI (British Standards Institution) for several years and was involved in writing European Directives and ISO/EN standards. He set up the BSI Notified Body for the MDD/93/42/EEC Directive covering medical devices. He worked as the RA/QA Director of a large multinational medical device company Ansell UK Ltd for over 13 years before joining Gama Healthcare Ltd. In his early career as a Research and Development Scientist he formulated extremely successful oil based and polymeric consumable products.