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Validation
NextPhase Medical Devices

validation-medical-devices

Process validation for medical device success

NextPhase Medical Devices has a long history of medical device validation, and we are ready to help ensure that your product meets requirements. Medical device is what we do, so validation conformance to FDA, MDD, and ISO standards is second nature. It is likely that we already have experience with the type of processes that 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.

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 will receive an effective, relevant, and well-documented validation plan and reports that meet all the regulatory requirements.

Examples of manufacturing process validation NextPhase has supported

  • Aseptic filling
  • Clean room ambient conditions
  • Heat-treating
  • Lyophilization
  • Plastic injection molding
  • Plating
  • Sterile packaging-sealing
  • Sterilization
  • Product assembly and testing
  • Production equipment
  • Production software

Types of validation that we use

  • 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 following regulations

  • FDAs quality system regulation
  • ISO 9001:2008
  • ISO 13485:2016
  • ISO 14971:2012
  • OSHA standards
 

Ask about our validation protocols for your device success.