Medical Device Services
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Carefully developed medical devices start here
Now more than ever, developing medical devices takes a keen eye for quality. To help you navigate the regulatory and development landscape while sticking to budgets and timelines, we start with the big picture in mind.
Regulatory know-how
Our regulatory consultants understand the landscape better than anyone. After all, many of them are former regulators themselves. No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, assist with investigational device exemptions, 510(k) applications, and more.
Sound compliance guidance
Our compliance experts can help at all stages of development to help you create and maintain a smart quality system, including design controls to meet FDA, EU, and ISO 13485 requirements, among other qualifications.
Combination products
As modern medicine advances, so do the ways in which pharmaceuticals and medical devices work together. With decades of experience in both categories, we put our hearts into creating custom strategies to guide your development to success.
