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QMS Pack

Comprehensive QMS Documentation for Regulatory Compliance

A well-structured Quality Management System (QMS) is essential for medical device and In Vitro Diagnostic (IVD) manufacturers to comply with international regulations such as ISO 13485:2016, EU MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, and UK MDR. Our QMS Documentation Pack ensures complete compliance, facilitating seamless audits and regulatory approvals.

Our QMS Documentation Pack Includes:

Quality Manual & Quality Policy

  • QMS structure and framework aligned with ISO 13485 & regulatory requirements.
  • Quality policy and objectives to ensure continuous compliance and improvement.

Standard Operating Procedures (SOPs) & Work Instructions

  • Document & Record Control Procedures
  • Risk Management (ISO 14971:2019) & Hazard Analysis
  • Design & Development (21 CFR 820.30, MDR Annex IX)
  • Supplier & Purchasing Controls
  • Production & Process Control Procedures
  • Complaint Handling & CAPA Management
  • Change Control & Device Modifications

Risk Management & Regulatory Compliance Documents

  • Risk Management Plan & Reports (ISO 14971)
  • General Safety & Performance Requirements (GSPR) checklist
  • Device Master Record (DMR) & Device History File (DHF)

Clinical & Post-Market Documentation

  • Clinical Evaluation Reports (CER) / Performance Evaluation Reports (PER)
  • Post-Market Surveillance (PMS) & Vigilance Procedures
  • Post-Market Clinical Follow-Up (PMCF) Plan & Reports
  • Periodic Safety Update Report (PSUR)

Internal Audit & Management Review Documentation

  • Internal Audit Procedures & Checklists
  • Management Review Meeting Templates
  • CAPA & Non-Conformance Management System

Training & Personnel Records

  • Employee Training & Competency Records
  • Job Descriptions & Responsibilities

Validation & Verification Documents

  • Software Validation (ISO 62304) & Process Validation Templates
  • Equipment Calibration & Maintenance Records

Who Needs Our QMS Documentation Pack?

Contract Manufacturers & Suppliers

Medical Device & IVD Manufacturers preparing for ISO 13485 certification, MDR/IVDR compliance, or FDA approval.

Medical Device & IVD Manufacturers

Startups & SMEs establishing a regulatory-compliant Quality Management System.

Distributors & Importers

Regulatory Consultants requiring ready-to-use, audit-ready QMS documentation.

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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