Tony Blank

CoFounder & Senior Advisor at Barton & Blank, LLC | Chelmsford, Massachusetts, United States

About Tony Blank

Tony Blank, as Co-Founder and Senior Advisor at Barton & Blank, LLC, brings over two decades of invaluable regulatory affairs experience to the medical device industry. Since co-founding the firm in 2013 alongside Marlene Barton, Tony has played a pivotal role in establishing Barton & Blank as a trusted partner for companies navigating the complex landscape of global regulatory requirements. His extensive expertise encompasses a diverse range of medical devices, including interventional cardiology products such as drug-eluting stents, endovascular devices, cardiac rhythm management systems, and ophthalmic surgical equipment.

At Barton & Blank, Tony is instrumental in guiding clients through the intricacies of premarket submission strategy and execution, ensuring that their products meet the stringent standards set forth by regulatory bodies. His proficiency in regulatory submissions, including Premarket Approval (PMA) and Investigational Device Exemption (IDE) processes, has enabled numerous clients to secure timely product approvals, thereby accelerating their time to market. Additionally, Tony's deep understanding of the Medical Device Directive and ISO 13485 standards allows him to provide comprehensive support in design control, technical file preparation, and quality system management.

Key projects under Tony's leadership have included successful negotiations with regulatory agencies, where his strategic insights and negotiation skills have proven essential in overcoming regulatory hurdles. His commitment to excellence in regulatory affairs not only enhances the operational efficiency of his clients but also fosters innovation within the medical device sector. As a thought leader in the industry, Tony continues to share his knowledge through mentorship and collaboration, empowering the next generation of regulatory professionals to navigate the evolving landscape of medical device regulations.

Tony Blank Work