![]() ![]() Having a validated process confirms the process makes good medical devices consistently. Often these characteristics are determined by the materials used to make the medical devices, but also how those materials are processed to make the device. These characteristics may be such things as it’s flexibility, strength, or hardness. Validated Processes are needed in making medical devices when an essential characteristic of the device cannot be tested after it is finished being made without destructively testing it. Further, ISO 13485 includes requirements specific for traceability during distribution of implantable devices handling of medical devices and components to protect them from contamination or alteration cleaning and handling of sterilized medical devices and requirements for validating processes. For example, ISO 13485 focuses on work environment controls that ensure product safety, an increased focus on risk management, and design control options that should be considered during product development. This is where ISO 13485 comes in.Īs a quality management system, ISO 13485 addresses concerns specific to the medical device industry. Implanted medical devices must adhere to some of the most rigorous safety standards available. Why is ISO 13485 so important? The majority of medical PEEK components are implanted in the patient, and even the slightest error in material processing or delivery could pose a problem. ![]() ISO 9001 is a start, but ISO 13485 has more focus on the priorities needed for medical device manufacturers and medical grade PEEK suppliers. ISO 13485 certification – Medical device manufacturers have a higher standard than the general guidelines found in ISO 9001 to which they can be certified. With ISO 9001:2015 certification, medical grade PEEK suppliers have the fundamentals of quality management in place.Ģ. ![]() Once a polymer fabricator has integrated ISO 9001 standards into their processes, they are regularly audited by a third party to verify ongoing compliance and maintain certification. ![]() These guidelines work in any field, but are particularly useful for polymer fabricators because the industry is constantly changing. The ISO 9001:2015 set of requirements is a 10-section document that includes extensive guidelines on process planning, operation, support, leadership, evaluation and improvement. In this way, ISO 9001 is the foundation of a quality management system, and is used to craft quality-first processes. ISO 9001:2015 certification – ISO 9001 is a set of quality management standards that any business can implement to improve their processes. Here’s how a supplier demonstrates their commitment to quality, and the signs that every medical facility should look for:ġ. There is no room for error when implanting a device, replacing a joint or fusing the spine, so medical grade PEEK suppliers must not compromise on quality or safety in any way. High-performance polymers exhibit properties that make them useful in demanding applications, and this is even more relevant when medical grade polymers are involved. How do medical grade PEEK suppliers ensure quality manufacturing? Is your PEEK fabricator doing all of that? Medical facilities should consider what their supplier is doing to guarantee this quality, as patient well-being is often at stake. It takes a never-ending commitment to developing the right processes, making adjustments when needed and adhering to all industry regulations. Medical grade PEEK suppliers are in great demand, but not all of them are equipped to consistently deliver high quality, safe components. ![]()
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