Expert Services

Technical Documentation Pack

Comprehensive Technical Documentation for CE Marking & Global Compliance

Ensuring compliance with EU MDR 2017/745, IVDR 2017/746, ISO 13485, and global medical device regulations requires a well-structured Technical Documentation Pack. We provide complete regulatory technical dossiers, ensuring seamless compliance with European and international regulatory bodies.

Our Technical Documentation Pack

Technical File for CE Marking (MDR & IVDR)

We prepare complete Technical Documentation (Annex II & III of MDR 2017/745 and IVDR 2017/746), including:

  • Device description & specifications
  • Design & manufacturing information
  • General Safety & Performance Requirements (GSPR) checklist
  • Risk management & usability engineering
  • Pre-clinical & clinical data
  • Labeling & IFU compliance

Risk Management File (ISO 14971:2019)

We develop a structured Risk Management File, including:

  • Risk Management Plan & Report
  • Hazard identification & risk analysis (FMEA, FTA, etc.)
  • Risk control measures & benefit-risk analysis
  • Ongoing risk evaluation & mitigation strategies

Clinical Evaluation Report (CER) - EU MDR 2017/745

Our CERs comply with MDCG 2020-13 & MEDDEV 2.7.1 Rev. 4, covering:

  • Clinical data collection & literature review
  • Equivalence analysis
  • Clinical study reports (if applicable)
  • Benefit-risk assessment & PMCF planning

Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF)

We ensure robust post-market compliance with:

  • PMS Plan & PMS Report (Annex III - MDR & IVDR)
  • PMCF Plan & PMCF Report
  • Vigilance & incident reporting

Periodic Safety Update Report (PSUR) & Summary of Safety and Clinical Performance (SSCP)

We prepare:

  • PSUR (for Class IIa, IIb, III devices) – Periodic updates on device safety & performance.
  • SSCP (for Class III & implantable devices) – Publicly accessible clinical performance summaries.

FDA, UKCA & Swissmedic Documentation Support

We assist in preparing regulatory technical files for:

  • 510(k), PMA & De Novo submissions (FDA - USA)
  • UKCA Technical Files (MHRA - UK)
  • Swissmedic Compliance (Switzerland - MedDO)

Who Needs Our Technical Documentation Services?

Contract Manufacturers & Suppliers

Medical Device Manufacturers seeking CE Marking, UKCA, FDA, or Swiss compliance.

Medical Device & IVD Manufacturers

Startups & SMEs needing structured regulatory documentation.

Distributors & Importers

Regulatory Consultants requiring expert dossier preparation.

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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