MPL excels among medical device manufacturers and packaging companies.
The guidelines for introducing new medical products are continually updated, and MPL has extensive experience with meeting the standards and regulatory controls established for use in the US. The development of new FDA medical devices requires the expertise of a number of different disciplines, from compliance research, engineering, medicine, marketing, and the design field, to coordinate successful projects and deliver maximum value to the marketplace. MPL follows the applicable guidelines for all of its contract medical manufacturing work, and guides its clients through all aspects of FDA medical device production.
MPL makes Class 1 and 2 medical devices for a wide spectrum of applications. The FDA uses three classifications for medical devices. Class 1 devices are low risk and subject to the fewest regulatory controls. Class 2 devices are considered to present higher risks than Class 1, with subsequently greater regulatory controls. To provide reasonable assurance of the device’s safety and effectiveness, MPL’s research team will develop a full report of the current regulatory status, including the submission of a 510(k) premarket notification.
Before a device can be introduced to the market, the manufacturer must receive a letter from the FDA which finds the device to be substantially equivalent (SE) to an existing product in the market that is already deemed to be compliant. This pre-notification order is known as a 510(k) and clears the device for commercial distribution. MPL regularly applies for these clearances, and manufactures FDA medical devices in association with their clients. When the manufacturing process is complete, MPL can also develop the best type of packaging for the project. Creating an attractive brand identity is a critical part of a product’s success, and, as one of the premier medical device packaging companies in the country, MPL’s team can produce packaging that fits your company image precisely.
MPL helps customers understand the regulations that apply to their products, and streamlines the clearance and approval process for FDA medical devices. Discuss your specific set of requirements with MPL and take advantage of the range of resources we offer for all types of contract medical manufacturing. For medical device manufacturing that makes medical devices the right way, look to MPL for reliability and compliance you can count on. You can submit a New Product Request Form here.