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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

Artificial Intelligence: What you need to know about next-gen smart medical device compliance

Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is having a significant impact on the evolution of smart devices and how healthcare will be delivered in the future. AI, coupled with machine learning, is calling into question what it means to approve a medical device capable of...

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...