• The medical industry is considered more sensitive. Any business venturing into the medical industry is required to follow stringent regulatory requirements. Furthermore, when it comes to the health and safety of the patients, healthcare professionals depend on medical devices. Therefore, ensuring that the medical devices manufactured are of high quality is crucial for customers, stakeholders, patients, and others.
• There are quality systems like ISO 13485 certification and standards for medical devices manufacturing and managing that must be met. These practices ensure the quality, safety, and function of medical devices. It can also convince the customers that the medical devices are reliable for them to use.
• The ISO 13485 certification does not spell out the specific measures for medical device manufacturers. However, the certification gives assurance to the people that quality happens at every stage of manufacturing that enables maintaining a high standard for medical devices.
What is a Medical Device?
- A medical device is an instrument or machine that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.
What is ISO 13485 Certification?
- ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series.
- The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to disposal of medical devices that are safe for their intended purpose.
- The ISO 13485 standard also provides a planned structure and realistic foundation to stick to medical device directives, regulations, protocols, and responsibilities. The standard essentially enables you to fulfill the medical device manufacturers’ commitment to the safety and quality of medical devices.
- The ISO 13485 certificate can be obtained by any company manufacturing medical devices irrespective of their size or location. The ISO 13485 implementation is carried out by companies in almost 21 countries.
Who Requires ISO 13485 Implementation?
- ISO 13485 certification is required for designers, distributors, and manufacturers of medical devices. However, suppliers and service providers can implement ISO 13485 and gain a competitive advantage by enhancing the brand’s credibility and recognition.
The ISO 13485 standard is applies to
• Medical device manufacturers (MD) or manufacturers of in vitro diagnostic products (IVD)
• Manufacturing of reagents or substances for use in IVD or MD
• Medical device suppliers
Benefits of ISO 13485 Medical Devices Quality Management System