22 Mar PROTECT YOURSELF – PROTECT OTHERS!
Being in the Medical Industry, we all understand the importance of a medical device as these both support and save lives and therefore require meeting the relevant quality standards.
However, the Presence of safety and standards are often hard to see, visually products can look the same, but are they? Let us show you what makes our products different.
WHAT IS THE SA REGULATORY REQUIREMENT FOR MEDICAL DEVICES?
The Medicines and Related Substances Act No. 101 of 1965 states:
Medical device establishments must apply for a licence from the South African Health Products Regulatory authority to manufacture, import, export or act as a distributor as per section 22C(1)(b);
Medical device establishments are required to have a quality management system implemented based on the ISO 13485 standard for medical devices.
At Hutz Medical, we understand the importance of product safety and quality. That’s why we have been ISO 13485 certified and have a SAHPRA licence since 2017.
SO HOW DOES ISO 13485 HELP?
- Ensures Medical devices are manufactured with safety in mind.
- Makes sure that product risk is acceptable.
- Ensures customer satisfaction.
- Meets regulatory compliance requirements.
- Ensures full traceability of medical devices.
- Controlled processes due to regular on site audits.
Our medical devices are manufactured with the use of relevant standards, using documented and controlled processes. Our products are 100% tested which increases the confidence in the safety of our products.
WHY ISO 13485 AND NOT ISO 9001?
ISO 9001 is a general quality management standard that is suitable for any organization, regardless of its field of activity. It provides a framework for quality management, but does not include all the specific requirements for the medical device industry.
ISO 13485 on the other hand is an international standard for a quality management system and forms part of the licencing requirements of the South African Health Products Regulatory Authority.
ISO 13485 is:
- The applicable Quality Management System for medical devices;
- Required to ensure compliance with regulatory requirements;
- Needed for risk management and products safety;
- Ensuring full traceability of medical devices;
- Validating customer satisfaction through post market surveillance;
- Ensuring the well-being of the public (end user).
WHAT ASSURANCE CAN AN ISO 13485 CERTIFIED COMPANY PROVIDE?
- Regular onsite audits (TUV Rheinland).
- Extensive product testing (Internal / External).
- High levels of reliability in production.
- Timely recall, correction and replacement of any defective medical device.
- Extends quality beyond the company by monitoring suppliers and putting
measuring controls in place.
HOW DOES AN ISO 13485 CERTIFIED COMPANY ASSURE PRODUCT SAFETY?
Products manufactured by an ISO 13485 certified facility are tested against established standards for medical devices, such as:
- IEC 60601-1 Medical electrical equipment
- IEC 60601-1-2 Electromagnetic Compliance
- ISO 11197 Medical Supply Units
- ISO 7396 Medical Gases and Vacuum Systems
- ISO 5359 Low Pressure Hose Assemblies
- ISO 19054 Medical Rail for Supporting Medical Equipment
- ISO 14971 Application of Risk Management to Medical Devices
- IEC 62366 Application of Usability engineering to Medical Devices
WHY CHOOSE HUTZ MEDICAL?
- ISO 13485 Certified since 2017.
- Hutz Medical: SAHPRA licence to supply and manufacture in SA since 2017.
- Hospi-Tec: SAHPRA licence to supply and manufacture is SA since 2019.
- Products carry the CE mark.
- More than 6000 projects successfully completed.
- More than 35 years’ experience.
- The ability to customise products to the client’s requirements.
- A continuous improvements policy in all aspects of the business.
Protecting yourself and protecting others starts with product safety! Avert legal risks and get in touch with our specialised team to ensure your medical products comply with ISO13485 standards.
Now ask yourself…Does your supplier comply with the regulation and does their product conform to the relevant standards to ensure their medical devices perform as intended?
Published Date: 22-03-2023