Before bringing your device to market, you must ensure it meets all regulatory requirements. But without the right resources to manage the complex process for the review and approval of your medical device, you run the risk of delays and rising costs. That’s where we come in.
At Sterling, our team comprises the best regulatory experts in the industry. Each of them brings extensive experience in medical device design and development. Our medical device clinical research and regulatory services span every stage of development, from preparing early regulatory strategies for preclinical interactions to commercial and post-marketing activities. We’ll guide development and submission strategies and, when needed, stand in as an extension of your regulatory team to get you over any unexpected hurdles. We’ve completed hundreds of projects like yours; we know what’s involved in demonstrating that your device is safe, effective, and performs as intended while ensuring it delivers a positive experience to the people who use it.
Our medical device clinical research and regulatory services include:
Sterling will act as your executive regulatory representative at regulatory authority meetings, and coach you through your communication and interaction strategy. We’ll proactively evaluate the optimal time you’ll need to positively engage with regulatory authorities, identify the critical questions and plans necessary to obtain an agreement to move forward, and develop meeting requests and strategic positions. We’ll also guide you through practice and pre-meeting coaching sessions to prepare you for communication with regulatory bodies, and, if desired, lead the actual collaboration with regulatory authorities on your behalf. Sterling’s medical device clinical research and regulatory team has deep experience in QSubs and Additional Information Request meetings with the US FDA, and other comparable meetings with worldwide regulatory authorities.
We’ll see your programs through marketing applications (PMAs, 510(k)s) De Novo’s, IDEs, and beyond. We’ll advise you on critical late-stage development programs to ensure success, and act as consultants, authors, and everything in between.
We’ll prepare and submit special designations applications, such as 513(g)s, Emergency Use Authorizations (EUAs), breakthrough designations, and HDEs, to help bring your product to market.
We’ll advise you on developing content for the clinical trial documentation (IDEs, CRFs, Trial Binders, IRB submissions, Patient Brochures, etc.), and can even stand in as the authoring team to develop the content. We’ll also ensure the investigational application reflects the right approach for you at each stage of development.
We’ll help you develop and implement a regulatory strategy and provide information on key considerations that must be addressed. We’ll also anticipate issues and concerns with regulatory authorities and stakeholders, and even define key program milestones—which, for many businesses, are the catalysts that drive investor interest and financing.
Having worked with several client research, development, engineering, and scientific expert teams, our medical device clinical research and regulatory team will partner with you to incorporate insights and learnings gathered from developing similar products to set, advise on, and lead a custom-winning regulatory strategy. We’ll perform gap and readiness assessments for the current product development program and develop integrated plans and strategies as needed. Backed by our advanced regulatory intelligence, direct industry experience, and deep knowledge of the competitive landscape, we’ll also help you integrate potential regulatory approaches based on your development goals.
Led by our team of regulatory, clinical, quality, and product development experts, we can help you assess and evaluate the regulatory and clinical aspects beyond the intellectual property, commercial market, and scientific soundness through a thorough due diligence process. This process includes an assessment of medical need and feasibility with a focus on better understanding the market opportunity within the development landscape.
Our medical device clinical research and regulatory team will help you create usability files with all required documentation, complete formative and summative evaluations, conduct risk/benefit analyses, and ensure usability requirements are met across the entire product development lifecycle. We’ll also help you generate, collect, analyze, and evaluate clinical data to prepare for clinical investigations or clinical evaluations, handle regulatory submissions, manage investigational review board submissions, help you prepare for and run medical device clinical trials, and more.
With advanced expertise in human factors engineering, we want to help you ensure your medical device is not only safe for customers, but also supports optimal compatibility between the user and the device. A medical device is only as good as a human’s willingness and ability to use it. By applying human factors and usability engineering to the design and development of your device, you will minimize user error and, ultimately, human harm. From helping you understand requirements, drafting necessary documentation for usability specifications, and creating protocols to completing formative evaluations and conducting medical device clinical studies in a real-world setting, we’ll help you ensure your device supports safe and effective interactions with the end user.
Whatever your device class or individual circumstances surrounding the design and development of your product, our medical device clinical research and regulatory team will help you demonstrate it is safe and performs as intended so you can achieve regulatory approvals faster and get your device to market.
For more information about our medical device clinical research capabilities, contact us here.
January 26, 2022
February 18, 2021