For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is critical. They invest enormous amounts of money to develop and manufacture innovative and disruptive devices that can improve patient outcomes and save lives. They need to achieve this without compromising product safety, effectiveness, or regulatory requirements. There are other concerns, as well. Product development in this industry is expensive, and getting products to market quickly is a priority for medical device manufacturers–which makes it a priority for Motion Solutions. Our resources enable us to help manufacturers speed design, prototyping, production, and accelerate FDA approval, courtesy of our ISO 13485-compliant processes.
As a supplier to this industry, we offer:
- ISO 13485 certification
- Experienced engineers and technicians who understand the requirements of the standard and how to support them, including full design controls
- FDA and ISO 13485-compliant product lifecycle management software
- Rapid prototyping, courtesy of our in-house machine shop
- Specialty equipment to support test and inspection, such as coordinate-measuring machines, a laser interferometer, and an optical comparator.
ISO 13485 Compliance
ISO 13485 is an international standard that defines the requirements of quality management systems for the design and manufacture of medical devices. Certification to the standard demonstrates to our customers that we take quality very seriously and have the system and processes in place to ensure it.
Motion Solutions develops and manufactures products for the medical device industry. We apply our motion expertise so that the customer can concentrate on building devices that address medical needs and deliver improved patient outcomes. Strictly speaking, ISO 13485 compliance rests with the manufacturer of the device. As a member of the medical device supply chain, however, we consider compliance to be our responsibility, as well. Our ISO 13485 certification enables us to deliver fully compliant products with complete documentation and traceability.
One key aspect to our business is our internal design controls that enable us to offer customers a complete array of services and documentation, including design specifications/plans, risk management/FMEAs, verification and validation activities/reports, comprehensive design history files, etc. Our work is compliant with the standard while meeting the customer timelines and requirements. Because we use the process approach outlined in the standard, we have the ability to streamline product development and manufacturing, facilitating greater efficiency and cost savings. These capabilities help our customers to get safe and effective products to the market faster.
Whether in our engineering, manufacturing, or quality assurance department, Motion Solutions has the talent and personnel who understand quality and that can deliver. We have the tools, equipment, processes, and procedures to build compliant products and support them with documentation tailored to the needs of the customer. The combination enables us to help medical manufacturers get products to market fast while ensuring the highest quality.
About the Author
Vincent Cipolla is quality/regulatory manager at Motion Solutions.