QUALITY MANAGEMENT SYSTEMS

SERVICE BENEFIT: Planning, implementation and internal audits

As a medical device manufacturer, best practice requires compliance to ISO 13485 Quality Management System for Medical Devices.


We offer you the following QMS services:

  • ISO 13485 Internal Auditing;

  • ISO 13485 Planning (for new companies);

  • Establishing QMS documentation such as SOP's and Quality Manuals;

  • Integration of eQMS 

REGULATORY AFFAIRS

SERVICE BENEFIT: Planning, implementation and market-access

Regulations determine the compliance requirements for medical devices prior to reaching the market as well as at the post-market stage.


We offer you the following regulatory services:

  • SAHPRA Licensing (South African market);

  • Regulation (EU) 2017/745 Gap Analysis;

  • Regulation (EU) 2017/745 Implementation Planning;

  • Technical File Reviews;

  • Customer-Specific Regulatory Research

TECHNICAL DOCUMENTATION

SERVICE BENEFIT: Conformity to documentation requirements

We offer you the following technical documentation services:

  • Documentation Review (general);

  • Document Preparation (general)

  • Technical file Preparation;

  • Design History File Preparation;

  • Risk Management File Preparations;

  • Technical Documentation Templates;

  • SOP's and Processes;

  • Verification Testing Reports;

  • Instructions For Use Manuals (preparation and review);

Would you like to find out more about our services? Book a free consultation and get in touch!