Quality Management System Implementation & Independent Internal Audits
We help you comply with SAHPRA requirements. Bioqix is a consulting firm dedicated to Medical Devices.
We understand how overwhelming a QMS can be.
SAHPRA requires medical device manufacturers and distributors in South Africa to hold ISO 13485 certification, we have helped many organizations comply with these requirements.
Bioqix provides expert consultants, who have experience in the pharmaceutical industry, are qualified lead auditors and have experienced working with a certification body. Our consultants know what the registrar requires.
We can build or assess your QMS, help you fill the gaps, provide documentation support or perform an internal audit.
-
Save time and Reduce risk: find and fix the problems before the auditor does.
-
Create a self-managing company: optimize internal processes to improve efficiency, eliminate waste and improve customer satisfaction.
-
Develop competence: empower your staff through professional training.
Contact us today, so you can stop stressing about the health of your QMS and start focusing on other areas of your business: info@bioqix.co.za.
Services
01.ISO 9001 QMS Gap Assessment / Audit
Comprehensive internal auditing of your Quality Management System (QMS). We evaluate effectiveness, identify improvement opportunities, and support ongoing ISO 9001 compliance and certification application or maintenance.
02.ISO 13485 Medical Devices Gap Assessment / Audit
Specialized internal auditing against ISO 13485 requirements for medical device manufacturers, suppliers and distributors. We help ensure product safety, risk management, and regulatory compliance throughout the device lifecycle.
03.Implementation and Documentation Support
Comprehensive and practical implementation support, and documentation assistance. We help you identify compliance gaps, develop practical remediation plans, create or update SOPs, and ensure compliance .
04.Training
Live virtual workshops on ISO 13485:2016 - Awareness and Implementation (1 day) and Internal Auditor (2 days) and custom in-person/group offerings including ISO 14971, ISO 19011 and GCP awareness on request. Practical sessions for QA, RA, production and graduates. Certificate of completion after attendance.
Bioqix Academy
Empowering Professionals
Join a live virtual training from anywhere in the world!
ISO 13485:2016 - Awareness and Implementation Workshop
A practical 2-day workshop on the requirements of ISO 13485 and how to plan, conduct and report internal audits. Participants leave able to gather evidence, write findings and support a credible audit programme. Participants who successfully complete the training workshop receive a virtual Bioqix Certificate of Completion, which will be valuable to your curriculum vitae.
Duration: 1-2 days (virtual)
Format: Live online facilitation
Upcoming dates: 09 October 2026
ISO 13485:2016 - Internal Auditor
A practical 2-day workshop on the requirements of ISO 13485 and how to plan, conduct and report internal audits. Participants leave able to gather evidence, write findings and support a credible audit programme. Participants who successfully complete the training workshop receive a virtual Bioqix Certificate of Completion, which will be valuable to your curriculum vitae.
Duration: 1-2 days (virtual)
Format: Live online facilitation
Upcoming dates: 19-20 October 2026
Custom Offerings
Need something that is not on the standard list? We can design a virtual or in-person workshop around your team, product type and regulatory pathway.
Available on request:
-
Fundamentals of Medical Device Regulatory Affairs
-
Regulatory writing and technical documentation
-
Clinical evaluation
-
ISO 14155 (GCP for device investigations)
-
Post-market surveillance and PMCF
-
EU MDR overview
-
IEC 62366 usability engineering
-
Clinical quality assurance
Duration: Tailored
Format: Live online facilitation
How to Enroll in Training
STEP 1:
Complete the Enrollment Form
STEP 2:
Email your completed enrollment form to info@bioqix.co.za, we'll confirm your enrollment within 24 hours.
Bioqix is dedicated to Medical Device companies. The value we provide is centered around expert consultants who have experience in the pharmaceutical industry, and we have worked for certification bodies. Our goal is to empower businesses in achieving and sustaining ISO 13485 and ISO 9001 certifications while navigating the complexities of regulatory standards in South Africa. Our team of knowledgeable professionals is committed to simplifying compliance processes and enhancing operational effectiveness for our clients.