|
Covington is regulatory counsel to both start-up companies and large corporations, spanning a range of medical devices including implants, diagnostic and therapeutic equipment, in vitro diagnostic products, and computerized health information systems. Our lawyers advise clients on the full range of regulatory requirements and strategies for medical device product development -- clinical trials, marketing authorizations, dispute resolution proceedings, quality system regulations (QSRs), postmarket reporting and compliance, and advertising and promotion. We also have experience with the electronic product standards and requirements that are also applicable to non-medical products such as lasers and sunlamps. In conjunction with our London and Brussels offices, we can efficiently advise companies on device regulatory requirements on a global basis.
Representative Matters
- Represented several companies in connection with appeals under FDA’s medical devices dispute resolution procedures.
- Advised companies on regulatory strategies for obtaining premarket approval or clearance for new devices, including assisting in the development of strategic plans, and preparation for FDA meetings and Advisory Panel proceedings.
- Advised large and small companies in handling FDA inspections and responding to notices of inspectional observations.
- Conducted regulatory due diligence in connection with acquisitions and IPOs.
Accolades
- PLC Cross-border Super League (2005-2008)
- Ranked 1st in the Life Sciences Industry Super League
- Ranked 1st in the Life Sciences Regulatory Super League
- PLC - Life Sciences, Which Law Firm? (2006-2007)
- Leading: Regulatory firm, EU and USA
- PLC awarded Covington the Best International Practice Award 2006 in the life sciences area.
|
|
|
|
|
|
|