Regulatory, Clinical Strategy, Support and Submissions

  • Overview
  • Benefits of Regulatory Consulting
  • Why Work With NSF?
  • Services
  • Experts
  • Success Stories

NSF Health Sciences provides U.S. FDA and European regulatory consulting services to support the development, marketing and stewardship of medical devices, including in vitro diagnostics and combination products. Our services help resolve or avoid challenges as well as support the successful design and implementation of new, innovative products.

Our consultants bring FDA and industry expertise to your projects, and our network of subject matter experts, across all therapeutic areas, provides you with quality and expertise where you need it. We deliver balance between regulatory requirements and business needs.

For more information about NSF Medical Devices regulatory and clinical strategy support and submissions in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about NSF Medical Devices regulatory and clinical strategy support and submissions in Europe, email eudevices@nsf.org or call +44 1143 600 868.

Benefits of Regulatory Consulting

NSF's international regulatory affairs consulting services deliver the results you’re looking for:

  • Industry-recognized senior professionals from leadership positions in international regulatory agencies (FDA and EU) and the industry
  • Expert staff with in-depth knowledge of industry best practices for quality systems, product development and early-stage ventures
  • Proven record of success with complex projects and unique, innovative products
  • Global regulatory expertise spanning product types from high-risk implants to non-traditional device types (such as gels and injectables) to routine-use and home-use devices (such as drug-delivery systems)
  • Broad network of subject-matter experts across all therapeutic areas
  • Integrated approach to total product lifecycle and regulatory affairs

Why Work With NSF?

NSF maintains a commitment to outstanding service and quality. We focus on your business objectives through the use of sound science and proven expertise. Initial consultations are provided as a professional courtesy. Our expertise covers a wide range of therapeutic areas, product types and regulatory specialties.

Services

NSF provides a wide variety of services including medical device regulatory strategy,  clinical strategy and evaluation, expert witness, advisory panel support and submissions for 510k, PMA, IDE and design dossiers. Specific services include:

Strategic Consultation

Our team has extensive experience evaluating efficient and effective regulatory pathways for novel medical devices.We work with our clients to determine the most appropriate and least burdensome routes to market for first-in-class or other innovative technologies.

  • Regulatory strategy: Product classification, submission type, predicate device recommendations, applicable standards and guidance documents
  • Emerging regulatory issues: Mobile medical applications, combination products, etc.
  • Due diligence
  • Expert testimony

Regulatory Submissions and Support for Multiple Therapeutic Areas

Our team advises on regulatory submissions for medical devices across a wide range of risk profiles and therapeutic areas. We keep our clients up to date on regulations and regulatory authority expectations to ensure submission completeness and quality.

  • Pre-market submissions: IDE, 510(k), de novo, PMA, amendments and technical file/design dossier for European CE marking
  • Post-marketing submissions: PMA supplements, 510(k)s for changes, annual reports and post-market studies
  • Responses to deficiency letters and additional information requests

Product Development, Documentation Development and Evaluation

In addition to regulatory affairs experience, NSF delivers technical expertise to support the development and review of design control documentation in accordance with engineering principles.

  • Preclinical testing: Safety and performance testing plans, protocols and reports
  • Risk analysis: dFMEA, pFMEA, fault tree analysis and safety assurance cases
  • Design and development plans and traceability matrices

FDA and European Agency Interactions

We assist our clients in developing effective communications with regulatory authorities during all phases of product development from concept to post-market.

  • Informational, pre-submission and submission issue meetings
  • Competent authority scientific briefings
  • Advisory panel preparation and support
  • Dispute resolution and administrative appeal
  • Global regulatory filings and global strategies

Clinical Study Design and Evaluation, SR/NSR Determinations

We help you bring products to market quicker by supporting clinical documentation and designing studies that comply with regulatory requirements and meet business objectives.

  • Patient population identification and endpoint selection
  • Protocol development support
  • Statistical analysis plans
  • Report, manuscript and publication development
  • Human factors evaluations and labeling comprehension studies

Medical Devices Advisory Committee Panel Meeting Preparation

We offer complete strategic and logistics preparation and planning support services for sponsors at FDA panel meetings, with an emphasis on scientific and regulatory strategy.

  • Critical analysis and strategic assessments of key internal and external issues
  • Panel briefing and presentation materials development
  • Expert identification and management
  • Preparatory meetings and mock panels
  • Panel project management

Experts

Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practice.

Yvonne Middlefell, RAC, FRAPS - Executive Director

Ms. Middlefell leads our European regulatory strategy and clinical services and has extensive experience in global medical device regulatory affairs. She has worked for a number of key multinational corporations including Amersham Nycomed, Eastman Kodak, Bausch & Lomb and a 25-year tenure at Johnson & Johnson. Her RA experience includes developing global regulatory strategies for IVDs, medical devices, OTC products, biologics and pharmaceuticals. Ms. Middlefell has written and filed multiple CE technical files and US 510(k)s for a range of products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses and solutions.  In addition, she has successfully managed a full PMA for an IVD U.S. product submission. She was her company’s primary interface with regulatory agencies and industry bodies such as AdvaMed (USA) and EDMA (EU).

Meaghan Bailey, RAC − Senior Director

Meaghan Bailey is Senior Director at NSF Health Sciences Medical Devices. Ms. Bailey’s activities include analysis of complex regulatory challenges, development of regulatory strategies for innovative products, preparation of regulatory submissions, literature review and analysis, and assistance with preclinical and clinical programs. Ms. Bailey has particular expertise in preparing sponsors for FDA Medical Device Advisory Committee panel meetings. She has supported the development and commercialization of a wide variety of products including in vitro diagnostics, devices for the treatment of women’s health issues and mobile medical applications. She also has extensive experience in the area of diabetes management devices. She was previously the Healthcare Investor Events Manager at Guidepoint Global in New York City, an independent primary research firm to institutional investment funds. Ms. Bailey holds a Bachelor of Arts with highest distinction in human biology, an interdisciplinary distinguished majors program, from the University of Virginia. She graduated Phi Beta Kappa.

Deborah Baker-Janis - Director

Deborah Baker-Janis has over 10 years of experience in the medical device industry, including positions in both regulatory affairs and product development. Her experience includes the development of pre-clinical testing protocols, FMEA documentation, quality system and regulatory affairs standard operating procedures, sales training materials, MDR and safety reports, and domestic and international regulatory strategies and submissions. Ms. Baker-Janis has supported the development and commercialization of a wide range of products including animal tissue-based wound dressings and surgical meshes and interventional radiology devices including stents, catheters and guidewires. Her educational background is in biomedical engineering, which has proven to be an asset in understanding the technical challenges companies face in bringing products to market and in recommending solutions based on engineering principles.

Success Stories

Challenge: A small European medical device company sought to enter the U.S. market and expand its product portfolio.

Solution: NSF Health Sciences Medical Devices generated multiple regulatory strategies as part of a phased approach. Our early and continued involvement resulted in an intimate understanding of the product’s core technology and the company’s business goals, ensuring value-added strategy development. 

Challenge: A U.S. manufacturer of diabetes management devices needed regulatory support during PMA review.

Solution: NSF Health Sciences Medical Devices provided multifaceted support to the manufacturer during PMA review including assistance in developing responses to scientific and quality system deficiencies. Our in-depth approach involved SOP review, Q-submission meeting preparation, and further development and optimization of design control deliverables, which facilitated progression to a pre-approval inspection.

Challenge: A manufacturer of a PMA device with a significant new indication for use needed support preparing for an FDA advisory panel meeting.

Solution: NSF Health Sciences Medical Devices served as the focal point for managing all panel preparation activities from start to finish. Our client support was both strategic and tactical, designed to augment the internal capabilities of the client team. Our team helped the client identify strategic issues, develop effective messaging based on sound science and regulation, and navigate the regulatory requirements of the panel proceedings. NSF Health Sciences also arranged and ran practice sessions and mock panels, and managed the onsite panel process. The client was well-prepared with a clear panel presentation and the ability to respond efficiently and effectively during Q&A. The client had favorable voting outcomes by the panel.

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