Validations
Ken Block Consulting
Validation Requirements:
Validation Background:
FDA requires validations of finished medical devices, as well as for
software, hardware, and processes used in their design, development,
and manufacture. Validations are key to demonstrating the safety and
effectiveness of medical devices, in both FDA and ISO environments.
 | | FDA Software Validation Certification
|
| | Former Corporate Director, Engineering
|
| | Medical Device Instruments & Disposables
|
| | Cleanroom & Controlled Area Environments |
| | |
Validation Services Provided:
| | Validation Plans
|
| | Risk Analysis & Risk Management
|
| | Final Product Validations
|
| | Environmental Effects (Temperature/Humidity/Shock)
|
| | Packaging Integrity & Shipping Validations
|
| | Simulated Aging (Reliability/Shelf Life)
|
| | Sterility Assurance
|
| | Design Software Validations (Mechanical/Electrical/Optical/Thermal)
|
| | Revision Control & Configuration Management Software Validations
|
| | ERP/MRP System Validations
|
| | Complaint & CAPA Software Validations
|
| | Manufacturing Validations (Processes/Fixtures/Equipment)
|
| | Test Validations (Software/Equipment)
|
| | Software Validation Training |
| | |
Kenneth L. Block, RAC* - FDA & ISO Services to Medical Device Companies Worldwide
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
|
