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.
Medical Devices Must Meet Strict Regulatory Requirements
When it comes to medical device creation, it’s crucial that organizations follow strict guidelines to ensure the production of high quality and reliable products. Regardless of intended use, medical devices face some of the toughest regulatory guidelines of any industry. It is up to developers and innovators to understand these regulations and ensure compliance when designing and producing devices for the medical industry.
In the United States, medical devices are regulated by the Food and Drug Administration (FDA) and the Centers for Devices and Radiological Health (CDRH). Based on associated risk, medical devices receive a Class I, Class II, or Class III classification. While Class I devices carry the lowest associated risk, Class III devices have the highest. The level of regulatory control depends on device classification.
Outsourcing Medical Device Design & Production
Companies looking to enter the medical device industry often find it difficult and confusing to understand the different CFR’s associated with the design, development, labeling, and production of medical devices. This is enough to keep many organizations out of the medical device industry altogether. However, this probably isn’t the best choice. The medical device and diagnostic industry is worth over $300 billion.
Organizations looking to produce high quality medical devices could benefit significantly from partnering with a trusted medical contract manufacturing service provider. Outsourcing to an ISO 13485 certified contract manufacturer ensures the production of high quality devices that meet strict regulatory compliance requirements. But this is just one piece of the puzzle. Organizations must also look for a partner that’s easy to work with and understands the importance of treating their staff and partners with the respect and attention they deserve.
Southern California Medical Device Contract Manufacturer
Means Engineering works directly with each of our valued customers to help develop a solution that exceeds their expectations in regards to both quality and care. Our vertically integrated approach makes it possible for partners to maintain control and monitor every step of the manufacturing process. By handling everything in-house, Means Engineering provides increased visibility and simplified supply chain coordination.
If you’re considering venturing into the medical device industry, or you require assistance with your existing medical device design and/or production, we encourage you to contact us to see why we’re the Southern California contract manufacturer of choice. We look forward to hearing from you.