|
Keystone Regulatory Services, LLC |
Quality Management System Consulting |
|
ISO 13485:2003 is the world-wide recognized medical device quality system standard. If you market devices outside the US, you must keep your eye on this document. For Europe, Japan and Canada, various transition timelines to the 2003 version are presently underway. Keystone Regulatory Services provides complete transition services to the new standard from gap analysis and development, to implementation and training. The new standard introduces the quality system “process approach”. The ease with which you transition your quality system depends on how it was constructed in the first place. Our quality system gap analysis services will help you identify if you need a tune-up or major overhaul in order to achieve ISO 13485:2003 certification. Our in-house training seminars are available as an executive briefing, a one-day overview course and a two-day detailed seminar including auditing techniques using the process approach. While investing in upgrading to ISO 13485:2003, a wise Quality System Manager will take the opportunity to optimize it, eliminate extraneous procedures, combine similar procedures and make other value-added changes. An outside perspective can help make sure you’re not missing opportunities for consolidation or conversely, that you’re not trimming back too far. In addition transitioning mature QM systems, Keystone Regulatory Services assists new companies develop their own compliant quality management systems from scratch. We ensure that your QMS is tailored for your operations and designed for growth. We do not implement “SOP’s from a can”. We work with you to identify your core and supporting key processes, important metrics, quality objectives and other important QMS concepts. We then work with your staff to develop supporting structure and ensure competence. Keystone Regulatory Services also provides cGMP (21 CFR Part 820) assessment, implementation and training services. Let Keystone Regulatory Service assist you in your medical device quality system needs. Contact us to discuss your requirements. |
|
· ISO 13485:2003 Transition · ISO 13485:2003 Training · Quality Management System Gap Analysis · Quality Management System Development / Optimization · Implementing Quality Management Systems in “Virtual” Companies (Companies relying heavily on outsourcing.) · cGMP (21 CFR Part 820) |
|
To contact us: |
|
342 E. Main St. Suite 211 Leola, PA 17540 |