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Navigating regulatory and quality requirements in the medical device field can be complex—especially for startups and small companies managing limited resources, evolving strategies, and tight timelines. With the right support, it becomes a structured and manageable process.

 

The services cover both regulatory and quality activities for medical device companies, delivered on a project‑based or temporary basis.

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Quality System Support

  • Development and maintenance of QMS (ISO 13485, ISO 9001) documentation

  • Internal Audits

  • Design History File (DHF) and technical file support

  • Supplier Management

  • CAPAs

Regulatory Support

  • Preparation of  technical documentation (EU MDR, MDSAP, TGA) 

  • Gap analysis form regulations and standards

  • Document review, gap remediation, updates to standards

  • Submissions and replies to authorities

  • PRRC services

  • Label, IFU and marketing material review and support

Complaint Handling and Post-Market support

  • Complaint handling and investigations

  • Complaint trending and reporting

  • PMS documentation support (PSUR, PMS reports, SSCP, etc.)

Other Areas

  • Preparation of clinical evaluation documents

  • Review of clinical documentation (clinical evidence, summaries, supporting content)

  • Validations and Verifications

  • Risk Management (ISO 14971)

  • Biocompatibility (ISO 10993)

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