Expert review of innovative technologies

An expert reviewer of innovative medical solutions understands what it takes to develop, deliver, and maintain high quality health technologies, by staying current on technological advances, understanding how to protect and promote public health while supporting technological advances. Following national policies in a flexible environment, by holding multiple specialties.

Assessing advantages and risks, helping investors, whether governmental or private, evaluate a start-up potential to become a viable company, looking at all company’s aspects:  Technology’s level of excellence and potential impact,  leading team potential to implement the company’s goals,  clinical & regulatory plan, scientific background as well as the potential market and financial situation, not ignoring the challenges and  capability to cope with them.

 (Special interest: Nervous, Cardiovascular and Digital health)

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Clinical affairs

Achieving the key milestones during the clinical phase is essential to the product's introduction to the market. Seashell MSL provides expert support and advice during this critical phase, working with you to -develop concept proposals, protocol development and review (including definition of a reasonable set of efficacy and safety outcome parameters);submission to ethics committee (Helsinki, IRB), negotiate with investigators and more; recruit study sites, KOL's (key opinion leaders), Principal Investigators; recruit a CRO; liaise between the CRO and the company; and coordinate investigator meeting...read more

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MSL

 

Assure thoughtful, fair, balanced, and accurate exchange of current medical information related to products and relevant disease state. Provide innovative and strategic educational and scientific support as needed.Establish and develop professional relationships, effectively communicate current scientific knowledge with key opinion leaders to expand research, advisory, and educational partnership opportunities...read more

 

 

Strategy planning

Seashell MSL can help you define the best strategy to bring your innovative product or technology to the global marketplace. By facilitating the dialogue between your company, the clinical community, and the regulatory authorities, Seashell MSL develops the optimal route to product introduction/acceptance in the market...read more

 

Regulatory affairs

We work with international regulatory consultants and authorities to advise on global regulatory strategies. Seashell can assist with submission preparation, from start to finish...read more

 

International training

 

Bringing our academic teaching and in-hospital experience into the medical device industry, we:

 

• Train, educate and guide physicians, nurses and allied health care professionals on the proper clinical usage, programming and evaluation of investigational or post-approval innovative medical devices. Including: medical devices, installation/implantation, maintenance/upgrades, troubleshooting, inventory management.

 

• Develop and coordinate the operations, training, competencies, and policies for the staff. Orientate and train new staff and evaluate personnel.

 

• Development and training of international customer support centers...read more