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One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally.

At MEDIcept, we understand that medical device testing is a rigorous and complex process that can reduce risk for both the device manufacturer and potential investors. It is critical to ensure that all engineering documentation is complete and accurate and that the manufacturer can validate that the product works as claimed. If they fail to implement a successful validation program, their ability to produce and sell medical products is put in jeopardy. That, in turn, impacts their value as a business.

At our state-of-the-art testing facility we can help develop and implement qualification testing and process validation protocols and reports for packaging and aging qualifications, sterilization validations, and biocompatibility testing suitable for regulatory submissions. These same testing services can also be conducted at your facility on your processing equipment.

We’re experienced in validating many types of equipment, processes and systems used in a wide range of medical device manufacturing. Our in-depth understanding of regulatory and clinical strategies and what it takes to bring a medical product to market enables us to assist manufacturers in developing reliable, compliant validation programs to help gain FDA product approval.

If you’re a medical device manufacturer – or looking to invest in one – we invite you to contact us to learn more about our proven medical device validation services.

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MEDIcept

Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...