top of page

Quality Management Systems

Planning, implementation, and internal audits

As a medical device manufacturer or a third party, best practice requires compliance with ISO 13485 Quality Management System (QMS) for Medical Devices. The QMS ensures companies have a path to compliance and enables systems that meet the demand of regulators, customers, and the business market environment.

 

We offer the following QMS services:

​

  • ISO 13485 Internal Auditing;

  • ISO 13485 Planning (for new companies);

  • Establishing QMS documentation such as SOP and Quality Manuals;

  • Building and Integration of eQMS; 

  • Quality Systems Development and Optimisation;

  • Quality Investigations and CAPA Support to Good Manufacturing Practices (GMP).

Regulatory Affairs

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;

  • Data-Driven Regulatory Research;

  • Regulatory Strategy Development and Consultation;

  • Regulatory administrative Tasks, e.g. Submission Management.

Technical Documentation

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).

Training

Inspection readiness and Upskilling

We offer you the following training services:

​

  • ISO13485 training;

  • Inspection readiness;

  • Process optimisation training;

  • Organisational Change Management;

  • Good Manufacturing Practices Methods training;

bottom of page