Micro Engineering Solutions understands the development challenges faced by medical device OEMs, key among which is the need to produce early production parts for clinical trials that are indistinguishable from a final product and within a regulatory landscape that is extremely complex.
When embarking on a medical device development program, a proven and in-depth understanding of which regulatory requirements apply to a specific device — and also what the regulatory obligations are likely to be — is of paramount importance.
With decades of experience, Micro Engineering Solutions works as the regulatory advisor for its customers shedding light on regulatory compliance issues that can significantly impact the overall shape of a product development program. We ensure that the products produced in pilot production will receive regulatory approval at the clinical trial stage, where success depends on demonstrating that the device is safe and operates as users expect.
Producing accurate pilot products and completing successful clinical trials is fundamental to our customers, and as such we ensure that we implement well-designed and adequately controlled clinical trials. Micro Engineering Solutions dramatically reduces the commercial risk associated with getting a medical device to market by taking a genuinely integrated approach to device design, pilot production, testing, and validation.