Process validation for medical device success

NextPhase has a long history of medical device validation, and we’re ready to help ensure that your product meets requirements. Medical devices are what we do, so validation conformance to FDA, MDD, and ISO standards is second nature. It’s likely that we already have experience with the processes you have in mind and have designed, executed, and documented a similar protocol that we can leverage efficiently in getting the job done for you.

Validation protocols

Every week customers come to us with new concepts ready for manufacturing, so our engineers are also skilled at developing protocols for innovative processes.

We can help you with your protocol and test development, execution, data analysis, and report generation. You’ll receive an effective, relevant, and well-documented validation plan and reports that meet all regulatory requirements.

Our process validation capabilities include:

  • Additive manufacturing
  • Clean room ambient conditions
  • Heat treating
  • Material joining
  • Plastic injection molding
  • Plating
  • Sterile packaging sealing
  • Sterilization
  • Product assembly and testing
  • Production equipment
  • Production software

Types of validation:

  • Prospective
  • Concurrent
  • Retrospective

How we validate

  • Determine the need to validate
  • Determine what to validate—IQ, OQ, PQ
  • Write a validation protocol
  • Conduct the protocol and collect the data
  • Analyze the data
  • Prepare a report
  • Retain the documentation as a quality record

Meeting the regulations

  • FDA quality system regulation
  • ISO 13485:2016
  • ISO 14971
  • OSHA standards

Ask about our validation protocols for your device success.