07.21.22 -- Tips For Obtaining Your 510(k) FDA Clearance

When developing a part or device for the medical or optic industries, the goal is always to get that part to market as quickly as possible. The key to doing just that: developing a strong relationship with a molder early in the part design process.

Protolabs provides medical device and medtech companies with a dramatically reduced level of risk. Working with us directly, you know the ability of everyone in our “pool,” so you don’t have to white-knuckle it, wondering where and how your parts are being produced. 

Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.

Optimizing delivery along with the formulation is the key for successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

Advancements in the treatment of severe cardiovascular disease are a result of many lifetimes dedicated to furthering the understanding and treatment of cardiovascular disease. Modern developments in heart valve protheses have followed closely with advancements in available biomaterials.

Gaining the right product approvals and certificates for major markets is fundamental both to succeed and to ensure safety and effectiveness of every medical device. Properly defined and prepared submission reports help ensure that the submission contains the appropriate information requested by the various regulatory bodies for the specific product classification.