Medical Devices

Medical Devices Yocto LawOverview

Similar to all sectors of the Life Sciences industry, the Medical Device sector is crowded, competitive, and faces ongoing challenges in light of evolving regulatory affairs and healthcare frameworks and a shift in the traditional business environment. Providing effective and truly client-tailored legal guidance in this rapidly evolving sector hinges on an appreciation of the legal, business, scientific, and regulatory imperatives facing clients in this sector as well as an ability to understand the science and technology that underpins a client’s business. This ability becomes a direct indicator of the quality of legal work clients can expect to receive.

Clients in the Medical Device sector rely on Dr. Gabriella Chan’s multi-faceted background to develop lasting relationships of unparalleled value.

Yocto’s clients receive tailored, well-rounded, and pragmatic advice informed by:

●  in-depth knowledge of Medical Device Regulatory Affairs (certificate from Regulatory Affairs Professionals Society)

●  legal experience honed as Vice President of Legal Affairs at a nanotechnology company

●  an advanced scientific background with postdoctoral work in handheld medical devices

●  practical business experience working in start-ups that aimed to develop handheld diagnostic devices

●  experience working closely with scientific teams and world renowned researchers to commercialize academic inventions

 Contact Yocto for assistance with:

●  IP portfolio development and strategic management including: assessment, enforcement, exploitation and commercialization of IP assets

●  Freedom to operate analyses and business strategy

●  Corporate matters including founders’ and shareholders’ agreements and executive compensation packages

●  Commercialization matters including drafting, review, and negotiation of licensing, distribution, employment, confidentiality, non-competition, strategic alliances, collaboration, R&D, and outsourcing agreements

●  Corporate governance matters including directors’ and officers’ liability

●  Development of policy and best practices manuals and training materials including: company policies, privacy policies, and IP policy manuals, as well as IP fundamentals instruction manuals

●  Regulatory compliance matters including diagnostic device approval, clinical trial management, and market access matters

●  Online-presence matters including: terms of use and privacy policies, trade-mark, trade-name, and domain name issues

●  Privacy matters including compliance with CASL

●  Scientific Research and Experimental Development (SR&ED) tax credit program

●  Workplace Safety and Insurance Board (WSIB) compliance

See additional services.