Overview

Mr. Sutton supports US and international regulatory strategy and submissions for the MCRA Regulatory Affairs department. Mr. Sutton specializes in writing and reviewing regulatory submissions, developing overall regulatory strategy, and communicating with regulatory bodies and clients. MCRA’s Regulatory Affairs department has the staffing expertise in the neuro-musculoskeletal disciplines, and carefully cultivated relationships and experience with U.S. government agencies enabling clients to operate, expand, and achieve their long-term business objectives.

Overview

Mr. Tatem’s work at MCRA focuses primarily on regulatory affairs relevant to spine and orthopedic medical devices.

Overview

As a manager of regulatory affairs, Michael manages and supports various US and EU projects in the spine and orthopedic therapeutic area.

Overview

At MCRA, Ms. Mundstock supports CRO operations and provides oversight and management for all aspects of the development and execution of clinical trials/protocols including adherence to study timelines and budgets. Prior to MCRA, Ms. Mundstock spent 12+ years leading IDE clinical trials in the medical device start-up space where she partnered with multiple individual vendors and clinical sites to provide reliable clinical evidence to support regulatory approvals.

Sarah Welsh is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, and PMAs for clients. Sarah also works to develop regulatory strategies, product landscape analyses, as well as recommendations for pre-clinical testing and clinical data requirements. Additionally, she is very experienced with literature analysis and evaluations. Sarah also has experience in drafting and preparing international (EU) regulatory submissions, notably, Clinical Evaluation Reports.

Palmer Smith is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, IDEs, and PMAs. Palmer helps clients navigate intensive regulatory landscapes by developing strategies and recommendations that efficiently bring their devices to market. Palmer collaborates across all MCRA service arms to ensure all clients’ pre-market needs are met. Additionally, Palmer helps lead the Compassionate Use Program service at MCRA that provides clients and physicians a unique FDA-pathway to better treat patients.