Medical Device Regulatory Services

At Element, we deliver comprehensive submission preparation services including 510(k)s, Pre-Submissions, IDEs, HDEs, EUAs, breakthrough device designations, and STeP submissions. Our support encompasses risk analysis, Clinical Evaluation Reports (CERs), design assessment, and strategic test planning to optimize your path to approval.

We specialize in testing orthopedic implants, diagnostic tools, therapeutic equipment, medical device batteries, and packaging materials. Our expertise covers mechanical testing, environmental simulation, EMC testing, and microbiological evaluation to meet all regulatory requirements and support your submission success.

Our proprietary methodology streamlines non-clinical testing and marketing applications, backed by 30 years of experience. We provide comprehensive risk assessment, literature evaluation, and full project management support from design through commercialization, with established strategies for successful regulatory outcomes.

Comparative Analyses: Element offers proprietary methodologies that streamline non-clinical testing, ensuring a smooth process for marketing applications. Backed by over 10 years of experience and deep biomechanical and physiological expertise, we provide valuable insights for device comparison and evaluation.

Design Assessment: With 30 years of experience across various products, Element helps you make informed design decisions to ensure optimal performance and safety. Our experts guide you through every stage of product design to meet both functional and regulatory requirements.

Risk Analysis and Mitigation: We help you assess potential risks and create mitigation strategies to ensure your product complies with regulatory standards. Our risk management process minimizes challenges and strengthens your product’s marketability.

Strategic Test Plans and Regulatory Pathway: Element’s experts provide custom test strategies aligned with your regulatory goals, ensuring you meet compliance requirements. We offer tailored support to help navigate the regulatory landscape efficiently.

Pre-clinical Evaluations: We collaborate with you to create a comprehensive regulatory and pre-clinical testing strategy. Our team outlines the testing needed to support your product’s path to market and regulatory approval.

Clinical Evaluation Reports (CERs): Element’s regulatory experts draft full Clinical Evaluation Reports (CERs) and literature reports, ensuring compliance with Medical Device Regulations (MDR). We ensure your CERs are detailed and aligned with regulatory standards.

Project Management: Navigating the regulatory landscape can be challenging. Element provides end-to-end project management support, guiding your product from design through clearance or approval, ensuring a smooth and efficient path to market.

FDA Submissions and Reports: Element offers comprehensive support for FDA submissions, handling some of the most complex regulatory processes. We assist with various submission types, including:

• 510(k)s 

• Pre-Submissions / Q-submissions 

• Investigational Device Exemption (IDE) 

• Humanitarian Device Exemption (HDE) 

• Emergency Use Authorization (EUA) 

• Breakthrough Device Designation 

• Safer Technologies Program (STeP) 

• De Novos 

We also provide Deficiency Response Strategies and Support to address FDA deficiency notices and facilitate resolution, leveraging our established brand and collaborative approach.

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.