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.
Medical devices help ensure quality of life for people around the globe. Used for a variety of diagnostic and treatment purposes, these devices play an important role in safeguarding the well-being of our increasingly health conscious population. Thanks to medical devices, diseases get caught earlier, improving outcomes and decreasing the cost of healthcare for millions of Americans.
Creating devices for the medical industry requires extensive experience and knowledge of industry requirements. Medical devices are highly regulated for both quality and reliability. This is important, as many people rely on the safety and efficiency of medical devices. Perhaps more than any other industry, OEMs planning to produce products for the medical industry should partner with an experienced electronic contract manufacturer.
You have many things to consider when choosing an electronics contract manufacturer. Although you’ll probably spend some time negotiating price and other important aspects of your contract, electronic manufacturing certifications should remain non-negotiable. These important industry certifications ensure the CM you work with meets rigorous quality expectations as required by the industries they serve. Without proper certification, the CM simply cannot guarantee quality or that the product produced meets industry-specific regulatory compliance standards.
For organizations that produce or manufacture products, outsourcing provides numerous benefits. In addition to reducing costs and time to market, outsourcing part or all of production can significantly increase the quality of products produced. However, it’s extremely important that organizations make an informed decision when choosing to outsource.
