Quality Systems
Ken Block Consulting
Kenneth L. Block, RAC* - FDA & ISO Services to Medical Device Companies Worldwide
Quality Systems Requirements:
Quality Systems Background:
 | | FDA & ISO Quality System Audits
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| | Former Corporate Director, Quality Systems
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| | U.S. & International Audit Experience
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| | ASQ Quality Management Session Leader |
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Examples - Quality Systems Services Provided:
| | Establishing/Evaluating QSR/ISO Compliant Quality Systems
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| | Modifying Quality Systems to Include QSR/ISO Requirements
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| | Authoring Quality Manuals, Policies and Procedures
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| | Developing Work Instructions and Process Flow Diagrams
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| | Establishing Medical Device Reporting Procedures
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| | Ensuring Appropriate Design, Change and Document Controls
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| | Device Master Records & Device History Records
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| | Design History Files
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| | Complaint Handling & Investigations
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| | Corrective & Preventive Action (CAPA) Procedures
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| | Paper-Based and Software-Driven Quality Systems
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| | Quality Objectives & Management Reviews
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| | Quality Systems Training
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| | U.S. & International Audits (Suppliers/Sterilizers/Manufacturers) |
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Comprehensive quality management systems are required for all U.S.
companies involved with medical device design, development, and
manufacturing. Federal law containing the quality management
system requirements for medical device companies is contained within
21 CFR 820 - Quality System Regulation (QSR), also called the Good
Manufacturing Practices (GMP). The FDA is responsible for monitoring
the QSR compliance of all U.S. medical device companies.
In addition, the International Standards Organization (ISO) has
developed a quality management system standard for medical device
companies contained within ISO 13485:2003. This international
standard is optional for U.S. medical device companies having
domestic sales only. However, ISO 13485:2003 compliance is a
requirement for medical devices distributed internationally, including
Canada, Europe, and Australia. Compliance to ISO standards is
certified through independent Notified Bodies and must be
accomplished before placing the CE mark on a medical device.
Contact Information:
*Certification:
Kenneth L. Block has earned the Regulatory
Affairs Certification (U.S.) from the Regulatory
Affairs Professionals Society (RAPS). The RAC
(U.S.) is earned through professional examination,
regarding comprehensive knowledge of FDA and
related U.S. regulations, policies and guidelines in
the areas of medical devices, drugs and biologics.
The RAC (U.S.) designation is a mark of distinction
for regulatory professionals dealing with FDA
products and issues including strategic planning,
design & development, pre-market & regulatory
review, manufacturing quality systems, marketing,
post-approval and FDA interfacing.
Ken Block Consulting
1201 Richardson Drive
Suite 140
Richardson, TX 75080 | |
© 2007 Ken Block Consulting
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