Daniela Levy

About Daniela Levy

Education & Background

Daniela Levy, Advocate and Founder of Sterling Medical Registration Regulatory & Quality Consulting, holds:

• LL.B. Degree in Law
• B.A. Degree in Social Sciences

With over 27 years of expertise in the Medical Device Industry, Daniela specializes in global product registration and quality system implementation. Her career reflects a strong foundation in Law, Quality Assurance, and Regulatory Affairs, combined with a deep commitment to integrity, professionalism, and excellence.

Experience & Services

Daniela’s career includes serving as Vice President of Regulatory & Quality Affairs at Alpha Bio Tec Ltd, where she successfully led due diligence and project support during the company’s acquisition by Nobel Biocare AG.

She brings extensive experience working with manufacturing and marketing companies in the medical device sector, offering services in:

• Regulatory Affairs & Market Entry
  • Strategic planning for entry into European, U.S., Israeli, and Canadian markets
  • Engagements with European notified bodies
  • EU conformity assessment procedures
    

• Legal & Contractual Expertise
  • Drafting Distributor Agreements (local & international)
  • Suppliers’ Quality Agreements

• Risk & Clinical Management
  • Risk Management processes
  • Biological & Clinical Evaluation
  • PMS (Post-Market Surveillance), PSUR (Periodic Safety Update Report), PMCF (Post-Market Clinical Follow-up), SSCP (Summary of Safety and Clinical Performance)

• Quality Systems Implementation
  • Design, implementation, and maintenance of Quality Management Systems
  • Development of Medical Device Technical Documentation (Medical Device File/Technical File)
  • Compliance with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820

• Training & Auditing
  • Tailored training programs for medical device manufacturers
  • Gap Analysis and Quality Audits with organizational process-oriented insight 

Daniela’s multidisciplinary expertise ensures tailored solutions for clients navigating complex regulatory landscapes.

Quality Policy

At Sterling Medical Registration Regulatory & Quality Consulting, our fundamental objective is to contribute to a safer market by ensuring compliance of our clients’ products with all applicable regulatory requirements.

We are committed to:

• Delivering legal and regulatory services at the highest professional standard, with thoroughness, integrity, reliability, and transparency.
• Providing creative, multidisciplinary solutions that add value in managing diverse legal and regulatory matters.
• Offering personalized, high-quality service, advancing each client’s interests effectively and keeping them informed throughout the process.
• Maintaining and continually improving the effectiveness of quality management systems.
• Complying with all applicable requirements while enhancing customer satisfaction through our processes, services, and relationships.