With recent changes to the regulatory landscape in Europe, Torrey Pines Law Group has developed a dedicated service to assist our clients better understand the regulatory landscape in Europe and how to navigate it most efficiently. We are able to assist with the development of a Medical Device Regulation (MDR) strategy for your product, provide the necessary support for CE Marking certification, preparation of documentation for the Notified Body (NB), interpretation of current EU-MDR/IVDR regulations, and propose an effective path forward.
We are also able to provide a European Authorized Representative (AR) role as well as provide strategies about how to deal with the UK, post-BREXIT.
Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.
We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Gemany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.
San Diego CE Mark Law Firm - Orange County Medical Device Regulations Counsel - Los Angeles MDR Transactions - International Regulatory Advisors - Complex Regulatory Transactions - Regulatory Due Diligence Attorneys - Biotechnology Regulatory Lawyers - Pharmaceutical Approvals - Medical Device Clearances - 510K Artificial Intelligence (AI) Law