Medical device design and manufacturing requires expertise in three engineering disciplines: mechanical, electrical, and software. As a provider of medical machined parts, we operate within the mechanical engineering discipline. The planning stages of medical device design include research and discovery, specification development, prototyping, and documented testing. We work with our customers throughout all phases of the design and production process to ensure that the end product is safe, effective, innovative, and successful.
Developing precision parts for medical devices is one of our toughest and most exciting challenges. Medical device companies compete to deliver the best, most effective products in today’s demanding market. In order to succeed in planning and engineering medical parts, we need to excel in precision and safety — all within the framework of strict regulatory standards.
- Establish a robust medical device patient safety net in the United States
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
- Spur innovation towards safer medical devices
- Advance medical device cybersecurity
- Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a TPLC approach to device safety
This is important to medical component part manufacturers because the “US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.” The most important regulatory standards for medical parts machining are addressed with ISO 13485:2016. ISO is the world’s largest developer of voluntary international standards. ISO 13485:2016 is an internationally agreed upon quality management system standard for the design, development, production, and sale of products for the medical device industry. When a manufacturer achieves ISO 13485:2016 certification, it communicates to their customers that they are a trustworthy manufacturer of precision parts for medical devices.
In addition to the above, medical device manufacturers may need to comply with environmental requirements or to conform to regulations for chemicals and other controlled substances.
Success with Medical Machined Parts
“Producing a successful part requires a process that transforms raw materials into a final product that satisfies design requirements while taking into account both technological and geometric constraints. But, more than that, a truly successful process will also be cost effective for the business.”
Component parts for medical devices should be planned and engineered with the same care and attention to detail that is applied to the finished medical device. Medical machined parts must be precise and accurate. They must ensure that the device is safe for use in or on the human body. They must conform to complex safety regulations. At SPM, we have been accomplishing this, on time and on budget, for more than 40 years.