Regulatory Affairs

Understanding the regulatory environment is a key element in every stage of the medical device lifecycle, from early development, through marketing and post market.

KeyMedic offers Regulatory Affairs solutions, including:

  • Regulatory strategy: taking into consideration the product’s characterization, intended use, and the company’s business roadmap, we can develop a regulatory strategy that will meet your needs.

  • Regulatory plan: classification of the product, identification of relevant standards and regulations, gap analysis, selecting the fastest, most cost-effective submission pathway.

  • Pre-submissions: preparation / review of pre-submission files, preparing / attending pre-submission meetings, post meeting correspondence.

  • Regulatory submissions: compilation / review of submission files:

    510(k), De novo, IDE, PMA, HUD / HDE, EU MDR (CE), MDL (Canada), Amar (Israel), ARTG (Australia), Other – ask us

    Submission-related advisory meetings, response to deficiency letters, change notifications.

  • Clinical Evaluation: identification of regulatory requirements related to clinical evaluation, developing clinical strategy, clinical study protocols binders, IRB management, AE reporting.

  • Labeling Development: preparation/review of labeling materials for physicians and patients, review of marketing materials.

  • Post Market Regulatory Compliance: periodic review of standards and regulations, incident investigation and reporting, recall management, preparation / review of periodic reports, Post Market Clinical Follow-up planning, regulatory compliance training.

What We Do

KeyMedic provides consulting services to the medical device industry, specializing in regulatory, quality and compliance solutions.

To help you even more we collaborate with Parente Studio, a Design and Development company that can help bring your company and product to the highest professional level.

Strategic Regulatory Consulting

Strategic regulatory consulting, development of regulatory plan, clinical investigations, regulatory submissions and more.

Quality Management Systems

Establishment and implementation of Quality Management Systems, inspection preparation & readiness assessment and more.

Quality & Regulatory Complience

Design control, V&V, risk management, quality audits, post market surveillance, recall management and more.

Branding, Design & Development

Branding, Logo, Business Cards, Product & Packaging Design, Website, Conference Booths, Ads, Brochures, Labeling, Patient Leaflets, User Manuals and more.