When producing medical devices, medical device manufacturers must maintain a clean environment. This is important, as any bacteria or microorganisms can create a safety concern for patients. It’s also crucial that medical device manufacturers ensure that air pollutants don’t gather on small components, impacting their ability to function as desired. In order to keep medical devices free from contaminants, medical device manufacturers must assemble these products in a controlled environment. Using a cleanroom for medical device assembly ensures bacteria and pollutants do not impact the functionality or safety of medical devices.
Ensuring Compliance with Federal Regulations Regarding Medical Device Creation
Companies responsible for the creation of devices for the medical industry must meet strict regulations regarding the design, production, and labeling of medical devices. Regardless of the type of device and its classification with the FDA, medical device manufacturers must ensure adequate cleanliness throughout the entire manufacturing process.
The International Organization for Standardization (ISO) sets the standard for quality for the medical device industry. Companies that receive ISO 13485 certification have proven they have the tools and capabilities to ensure optimal cleanliness and contamination controls when producing medical devices.
What is a Cleanroom?
A cleanroom is a special room, typically inside a manufacturing facility with special filtration used to remove contaminants like dust, airborne microbes, and aerosol particles. Manufacturers often use cleanrooms to produce electronics, pharmaceuticals, and medical devices. In addition to cleanliness and contamination control, cleanrooms also control temperature, air flow, and humidity all of which can impact the quality of finished products.
Do You Need a Cleanroom?
Organizations often wonder whether they need their own cleanroom. For organizations creating medical devices, a cleanroom is important to ensure the quality and safety of finished products. However, finding the space and funding for a cleanroom could create a challenge. Many small and mid-size companies often struggle to justify the cost of implementing cleanroom operations into their facility. It takes a lot of people and training to ensure the safe and proper production of these important devices.
Companies can benefit from outsourcing medical device production to an ISO 13485 certified contract manufacturer like Means Engineering. Our team has years of experience and understands how to design and produce a wide range of medical devices. We offer state of the art cleanroom assembly to ensure optimal cleanliness and quality.
Right Sized Contract Manufacturing Services
When you work with Means Engineering, we work directly with you to develop a customized solution. Unlike larger contract manufacturing firms, we offer a personalized approach. No matter how big or small your project, our team stays in communication throughout the entire process.
Please contact us for more information about our medical device contract manufacturing services.