SUPERIOR QUALITY MANAGEMENT
Leaner processes to stay aheadSo how do we achieve it? It’s quite simple:
- Support customer requirements for timeline and cost effective products
- Validate our processes in the markets they operate in
Part of this strategy is to ensure total compliance to regulatory guidelines. We achieve this by leveraging our extensive industrial knowledge on various procedures – from product registration and CE marking, maintenance of the Device History Record (DHR) and technical file, biocompatibility testing and validation and support sterilization, to updates on regulations and communication of new/revised regulations and intellectual property protection.
In addition, all our facilities are accredited to leading medical and quality management systems.
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All Forefront Medical facilities are certified to latest ISO 13485:2016 version. All facilities are also compliant to MDD 93/42/EC which is the Medical Devices Directive for European Community, MHLW Japan’s Pharmaceutical Affairs Law (PAL) and Ministerial Ordinance #169, ISO 15378 which is focused on primary packaging materials for medicinal products.
All manufacturing facilities are registered under US FDA and Japan as Foreign Medical Device Manufacturer. Our China Jiangsu facilities currently holds a NMPA establishment registration for Class III Product registered (510K), as well as China National Medical Product Administrator (NMPA).
- EN ISO 13485:2016 Medical Devices – Quality Management System
- ISO 14001:2015 Environmental Management System
- ISO 45001:2018 Occupational Health & Safety Management System
- ISO 50001:2018 Energy Management System
- China NMPA Manufacturing license
- Japan Accreditation of Foreign Medical Device Manufacturer