Supporting the biotech, medtech and healthtech sectors
Medical Devices
Strategic planning, regulatory affairs, medical device vigilance, legal representation and data protection to improve time to market and maximise the probability of successful regulatory approval.
Medical devices face an increasingly complex regulatory environment. A manufacturer must consider markedly different regulatory approaches to get a product approved in Europe and the US.
If the product combines a medicine and a device or a biologic and a device, the difficulties of interpreting the regulatory requirements increase even further. In some situations, pinpointing the final product's application type and associated risk profile can be very challenging.
We have expertise in medical device development planning and advising on strategic regulatory planning and compliance. We can help you navigate the increasingly complex regulatory environment regarding medical devices and combination products (including drug-device and device-drug combinations) and in-vitro diagnostics (EU, UK and US Medical Devices Regulation).
We advise the biotechnology/MedTech and diagnostics industries, institutions, researchers, and investors regarding the development, regulatory approval, and postmarketing scientific support across a broad range of therapeutic areas and product uses, including:
- Single-use devices
- Implantable devices
- Surgical tools, systems, and accessories
- Drug delivery devices
- Diagnostic imaging and monitoring devices
- Medical device software, wireless systems, and mobile medical applications
- Products for consumer use, both OTC and Rx
- In vitro diagnostic (IVD) products, accessories, platforms and equipment
- Companion diagnostics
- Combination products (drug/device, biologic/device)