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LOKCONSULTING.NET

lokconsulting.net

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Get your own corner of the Web for less! Register a new .COM for just $9.99 for the first year and get everything you need to make your mark online — website builder, hosting, email, and more.
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lokconsulting.net | lokconsulting.net Reviews

https://lokconsulting.net

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1

Mark F Schenk

http://www.lokconsulting.net/index.html

Mark F. Schenk. To the Medical Device Industry.

2

Mark F Schenk

http://www.lokconsulting.net/services.html

Mark F. Schenk. To the Medical Device Industry. Experienced developing Quality Systems compliant with the following standards:. ISO 13485 - Medical Devices - Quality Management Systems. European Union Medical Device Directive (93/42/EEC). US FDA Quality System Regulation (21 CFR 820). Canadian Medical Devices Regulations SOR/98-282. US FDA - 510k Premarket Notification. European Union - Technical File Submission. ASQ - Certified Quality Auditor. Quality System Gap Analysis Audit.

3

Mark F Schenk

http://www.lokconsulting.net/experience.html

Mark F. Schenk. To the Medical Device Industry. Created and implemented new Quality Systems compliant with FDA Quality System Regulation (21 CFR Part 820), ISO 13485 and the Medical Device Directive (MDD 93/42/EEC). Created medical device new product development systems that decreased time to market. Achieved ISO 13485 certification within 9 months, CE certification within 1. Managed setup and qualification of multiple manufacturing and packaging lines. Served as Management Representative for multiple.

4

Mark F Schenk

http://www.lokconsulting.net/clients.html

Mark F. Schenk. To the Medical Device Industry. Vertebral Implant Company, Doylestown, PA. Manufacturer of Spinal Implants and Instrumentation. Developing Quality System Compliant with FDA QSR (21 CFR 820), ISO 13485 and MDD. Assisting with obtaining 510k approval. Medical Device Manufacturer, Prospect Park, NJ. Converting Quality System for ISO 13485 Certification. Serving as Quality System Manager. Orthopedic Company, Fort Washington, PA. Manufacturer of Orthopedic Devices. Manufacturer of High-precisi...

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