Medical Device Design, Development & Regulatory Legal Services

Medical Device Design, Development & Regulatory Legal Services

🌍 Markets We Cover


  • USA – FDA (Food and Drug Administration)

Guidance on QSR compliance, 510(k) submissions, De Novo requests, and FDA inspections.

  • European Union – EU MDR

Support with conformity assessments, notified body interactions, CE marking, and technical documentation under MDR.

  • Israel

Expertise in AMAR registration, Ministry of Health requirements, and local regulatory pathways.

  • Canada

Assistance with Health Canada licensing, Medical Device Establishment Licenses (MDEL), and compliance with Canadian Medical Device Regulations.

Integrated Service


  • Regulatory Strategy & Legal Advisory

Tailored strategies to meet global regulatory requirements, including risk-based approaches and legal opinions.

  • Contractual & Compliance Support

Drafting distributors agreements, supplier agreements, quality agreements, NDAs and ensuring compliance with cross-border regulatory obligations.

  • Design & Development Oversight

Professional management of early design stages to ensure smooth Verification & Validation (V&V).

  • Biological Evaluation & Product Testing

Root assessment of biocompatibility requirements (ISO 10993) and justification for product-specific testing.

  • Process & Equipment Validation

Planning and execution of packaging validation, sterilization validation, cleaning/disinfection validation, and software validation.

  • Risk Management & Liability Mitigation

Integration of ISO 14971 risk management with legal risk analysis to minimize exposure during audits and inspections.

  • Audit Readiness & Representation

Preparing clients for ISO 13485 certification audits and FDA inspections, with legal representation and defense strategies if findings arise.

  • Post-Market Surveillance & Vigilance

Advising on adverse event reporting, recalls, and corrective actions in line with FDA, MDR, and Health Canada requirements.


In Summary

With our integrated legal and industry expertise, we don’t just help you design and validate medical devices—we ensure they are legally defensible, globally compliant, and positioned for successful market entry.



For Legal Advisory & Services in Israel please visit: www.Danielalevylaw.com