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Keystone Regulatory Services, LLC |
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Our Philosophy: Like the keystone at the apex of an arch, a regulatory strategy will have an impact on your organization. If it’s too small, it won’t sustain your structure. Too large and it will overwhelm your organization. |
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Welcome to Keystone Regulatory Services, LLC! We are a full-service regulatory affairs and quality system consulting organization for the medical device industry. Our goal is to help you solve your regulatory and quality system problems using a practical, yet thorough approach. Our services include quality system and risk management system analysis, auditing, implementation and training, premarket regulatory support, dispute resolution plus many others. See our service list for a complete listing. Visit our site often to keep current on industry news. Our useful links page contains references to many helpful sources of information for the medical device industry. Please contact us to discuss your regulatory affairs and quality system needs. We look forward to serving you! Bill McLain, RAC |
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342 E. Main St. Suite 211 Leola, PA 17540 |
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To contact us: |
Quote of the Week |
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Never let your persistence and passion turn into stubbornness and ignorance.
- Anthony J. D'Angelo
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Important Deadline:Device manufacturers certified to ISO 13485/88 must transition to ISO 13485:2003 by July 31, 2006 in order to continue presumption of conformity to the MDD. It is taking device manufacturers several months to complete the transition. Get started now! Learn about our transition and training services to the new standard. |