integral consultancy specialized in mdr and mdr ivd regulations
Specialized legal advice on MDR and MDR IVD Regulations
From Lentisco, we understand that compliance with the Medical Device Regulations (MDR) and the Medical Device Regulations for In Vitro Diagnostics (MDR IVD) is not only a technical issue, but also involves a thorough understanding of the legal aspects governing the European market. Our team of healthcare law experts is dedicated to providing accurate and specialized legal advice, ensuring that your organization complies with all regulatory and legal requirements in an effective manner.
Legal advice on compliance with MDR and MDR IVD Regulations
Compliance with the provisions of the MDR and MDR IVD Regulations is mandatory and essential for the proper marketing of medical and diagnostic devices in the European Union. Our approach to the subject encompasses:
Review and pre-assessment of conformity
We assess the compliance of your products from a legal perspective, identifying potential risks and compliance gaps, and developing legal strategies to address and mitigate these risks.
Advice on regulatory compliance strategies
We provide comprehensive legal advice for the correct implementation of the requirements of the MDR and MDR IVD Regulations, including the interpretation and application of the relevant legal provisions.
Drafting and review of legal documentation
We assist in the preparation and review of the technical and legal documentation necessary for CE marking, ensuring that all documents comply with the legal standards required for commercialization.
Legal support in audits and legal procedures
We provide legal support during audits and procedures with notified bodies, ensuring that your company is prepared to comply with all legal requirements and successfully pass any inspection or review.
Specialized MDR and MDR IVD training for teams and professionals
The correct interpretation and application of the MDR and MDR IVD Regulations from a technical-legal perspective is essential for your company’s operations. From Lentisco, we offer specialized training that includes:
Training in technical legal aspects of MDR and MDR IVD
We provide detailed training on the legal implications of the MDR and MDR IVD Regulations, ensuring that your legal and regulatory team is fully informed and trained to handle the regulatory requirements.
Continuous updating of legislation
We offer ongoing training programs to keep your team up to date with the latest updates and changes in relevant legislation, ensuring that your company maintains proactive and up-to-date legal compliance.
Legal audit simulations
We perform simulations focused on the legal aspects of audits, preparing your team to adequately respond to legal reviews and queries during inspections by notified bodies.
Why choose Mastic?
Our legal advice is based on an in-depth and specialized knowledge of the MDR and MDR IVD Regulations, with a focus on mitigating legal risks and ensuring regulatory compliance. We offer legal solutions adapted to the specific needs of each organization, guaranteeing secure operations in compliance with current legislation.
Rely on Lentisco for expert advice to ensure effective and competitive compliance with the MDR and MDR IVD Regulations. Our commitment to legal accuracy and excellence ensures that your company is prepared to meet any regulatory challenge with strength and confidence.