Quality: Regulatory, Systems and Engineering

Quality is a cornerstone of any regulated industry and requires a high level of understanding of the subject in order to deliver solutions that are suitable for the size of the company, its products and its people. At Majakel Medical we pride ourselves on being able to provide support throughout the full spectrum of quality activities which are relevant to any industry.

 

Medical Device Regulatory Support

To us at Majakel Medical, it’s the people that make all the difference. Our highly motivated and experienced medical device consultants support our clients at all stages along with iso 13485, 21 cfr part 820 of the relationship including;

 

Quality System Development

  • Gap Assessment
  • System Development
  • Internal Audit
  • Mock Audit
  • Supplier Audit

 

Design Lifecycle

  • Software and Hardware Development
  • Project Planning
  • Requirements Definition
  • Specification Development
  • Risk Management
  • Traceability
  • Design Review

 

Product and Process Development

  • Prototyping
  • Manufacturing
  • Logistics
  • Verification
  • Validation

 

Submissions Support

 

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