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Source Plasma and Blood

The human blood and plasma industry plays a critical role in today’s healthcare system. We work with both Plasma Collectors and Device Manufactures including IVD manufactures. We provide comprehensive compliance and remediation services for plasma facilities across the country, including facility auditing, compliance remediation, and site licensing assistance to help clients meet FDA quality system regulations.

Our services include:

  • PPTA viral marker reporting
  • CLIA/COLA reporting
  • State regulatory filings
  • Regulatory strategy, assessment and compliance
  • CBER Biological Licensing Applications (BLA) Submissions – including PAS, CBE30, CBE, and Annual Reports submissions
  • Batch record reviews & investigations
  • Validation and qualification
  • Laboratory methods validation
  • Computer/software validation
  • Site remediation
  • On-site training of company quality systems
  • Directive 2002/98/EC

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The Latest News

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...