Medical Device Verification and Validation Service

Majakel Medical’s consultants provide all aspects of healthcare device consultancy along with iso 13485, 21 cfr part 820, verification & validation. Verification and Validation is one of our specialty offerings, from single process optimisation and qualification through to complete product development, we can tailor a solution to suit. Whether your product is hardware, software or process we have the skills and experience to ensure that our solutions are robust, safe and cost effective.

Talk to our medical device consultants about our Managed Validation Program – whether it is moving equipment or even relocating site then let us take the risk out of your move by providing a comprehensive validation service. Tailored to your requirements, costs and timescales, we can plan and execute the activity through all stages. This could involve developing the Project Plan, identifying Resource Allocations, creating the Master Validation Plan, performing Risk Assessments, IQ, OQ, PQ, and all reports.

If you are developing a product then let us support you through all parts of the development and manufacturing lifecycle:-

  • Master Validation Plan development and reporting
  • Process optimization using Design of Experiments including response surface and Taguchi
  • IQ/OQ/PQ Protocol development, implementation and reporting
  • Measurement Systems Analysis including Gage R&R studies and Attribute Agreement
  • Capability studies and Statistical Process Control
  • Re-validation events and machine moves

If you are designing or procuring an automated process then we can also perform software qualification through GAMP5.

Examples of equipment and processes that we have successfully validated:

  • Laser, Resistance and Ultrasonic welding
  • Hydroxyapatite Robotic Plasma Spraying
  • Adhesive Bonding using Cyanoacrylate, two part Epoxy, UV curable, RTV
  • CNC Machining, Turning and Grinding centres
  • Automated Packaging systems including blister and pouch
  • Process test equipment including;
    • Leak
    • Blow and Dye penetration
    • High Voltage
    • Continuity
  • Automated labelling systems
  • Automated vision inspection systems
  • Robotic assembly systems
  • Compression and Silicon moulding

 

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