We help our clients with a variety of legal and regulatory compliance services. In today’s dynamic and high-risk world, it’s important to have a legal partner with experience in regulatory compliance and reputation for producing successful outcomes.
Regulatory Compliance Outcomes
Submitted and gained Traditional 510(k) clearance for diagnostic imaging device modification with no FDA questions. Submitted and gained clearance for pediatric ambulatory ECG device. Reviewed multiple 510(k)s to ensure they met FDA’s latest requirements and prepared responses to requests for additional information to assist clients in gaining clearance.
Completed gap assessment and remediated EU technical files for Notified Body audits. Supported Notified Body and MDSAP audits. Conducted gap assessment to EU MDR requirements.
Developed U.S. and international regulatory strategies for multiple products, including ECG monitors, diagnostic imaging equipment, infant care products and medical device accessories for small, mid-size and large companies.
Created and implemented 510(k), EU Technical File and other templates to standardize regulatory activity in a mid-size medical device firm.
Evaluated EU and U.S. product classification for novel sterile processing equipment, mobile medical apps, as well as other medical devices.
Created training for Good Clinical Practice, Introduction to U.S. Regulatory Environment and other courses for a mid-size medical device company.
Conducted due diligence for multiple investors to evaluate potential investments in medical device companies, including assessment of regulatory strategy and product classification.
Drafted research protocols, compiled documents for IRB submission and provided regulatory support of research studies. Observed and documented participants’ device interactions during a usability study. Author Human Factors report for FDA submission in accordance with FDA’s guidance.
Legal Service Outcomes
Assisted both emerging and mature clients in negotiating and closing a broad range of commercial contracts and transactions in order to commercialize new technology and achieve growth targets, including sales, supply, joint development/collaboration, licensing, distribution, consulting, co-marketing and non-disclosure agreements. Provided guidance on topics unique to the healthcare industry, such as contract terms related to recalls, adverse event reporting, complaint handling, debarment, registration of product licenses, and compliance with applicable healthcare regulations.
Lead lawyer in supporting the launch and implementation of a new product (software & services) offering as part of a cross-functional team, including counseling client on minimizing risk of becoming subject to financial industry regulatory requirements, creating a new contract template, equipping Marketing with pragmatic “do’s & don’ts” to ensure compliant marketing strategy, and real-time assistance in managing relationship with financial industry alliance partner.
Created and implemented a customized Healthcare Compliance Program for a rapidly emerging medical device company, including policies and training on anti-kickback and interactions with Healthcare Providers. Leveraged extensive in-house experience in collaborating with Senior Management to design a strategy that enables the client to be competitive and compliant in achieving its immediate goals as well as longer-term growth targets.
Created contract template and compliant process for medical device manufacturer to collect valuable product feedback from key customers.
Conducted due diligence for a venture capital fund to support an investment in a medical device company, including identifying key healthcare Compliance and contractual risks and proposing mitigation plans.
Freed up in-house Legal and Compliance teams by driving complex Compliance investigation from start to finish, including conducting interviews and fact-finding due diligence, handling report-outs to Senior Management, and recommending closure and remedial actions.
Assisted client in closing complex distribution deal with Swiss distributor in the Europe & Russia territories. Negotiations had been ongoing for 2 years and stalled prior to Kinetic’s engagement. Leveraged global experience and cultural intelligence to help progress the negotiations and close this high-revenue impact deal for the client.