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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:
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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:
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SAHPRA Licensing (South African market);
Regulation (EU) 2017/745 Gap Analysis;
Regulation (EU) 2017/745 Implementation Planning;
Technical File Reviews;
Customer-Specific Regulatory Research
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TECHNICAL DOCUMENTATION
SERVICE BENEFIT: Conformity to documentation requirements
We offer you the following technical documentation services:
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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!