Regulatory Affairs

Key to Global Market Entries

In the complex landscape of global certification, our specialized proficiency in regulatory affairs is unparalleled. We excel in interpreting and implementing international standards for medical devices, guaranteeing adherence to diverse regulatory prerequisites across varied healthcare systems worldwide.

FDA Regulatory Pathways

Regulatory Strategies

At Mecca, we offer strategic guidance spanning from initial development through compliance to follow-up phases in the complex medical device regulatory landscape. Our consulting team provides expertise to craft and execute Regulatory Compliance Strategies efficiently. We guide you toward achieving CE-mark, US 510(k), and global device registrations while aiding in establishing robust post-market surveillance systems. Our advice stems from extensive experience and active involvement in technical committees and regulatory forums.

Certification Supports

From interpreting CE/FDA regulatory requirements to crafting 510(k) and IVDR strategies and executing them seamlessly, we ensure compliance and market access. Our expertise extends to establishing Technical Files, devising robust regulatory compliance strategies, conducting Risk Analysis as per ISO 14971, Usability studies compliant with ISO 62304, and preparing documents for FDA/NB submissions. Additionally, we provide invaluable support in global medical device registrations and aid in understanding economic operator responsibilities.

TAILORED REGULATORY CONSULTING

We offer a wide range of consultancy services covering the field of compliance for medical devices and IVD.

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FDA Compliance Services

We provide comprehensive guidance and support throughout the device lifecycle, from the initial design phase through manufacturing, testing, and post-market surveillance. This entails navigating stringent standards, documentation requirements, and quality control measures, ensuring full compliance with the FDA's exacting expectations at every stage.

CE Marking Assistance

Our expert guidance is tailored to assist in obtaining CE marking, a crucial certification for medical devices seeking entry into the European market. We meticulously assess products, documentation, and processes, ensuring alignment with stringent EU regulations. This support encompasses thorough evaluation, verification, and validation processes, guaranteeing conformity and facilitating market access across EU member states.

Labeling and Packaging Compliance Solutions

Our services focus on meticulous attention to detail in developing compliant labeling and packaging materials for medical devices. We ensure that all information, warnings, and instructions are accurate, clear, and in line with regulatory requirements. By adhering to these standards, we aim to enhance user safety, minimize risks associated with misuse, and facilitate easy understanding for end-users.

Quality Management Systems (QMS) Supports

Our solutions align with ISO 13485 standards, fostering a culture of quality, compliance, and continual improvement throughout the organization. By implementing these systems, we ensure that processes are streamlined, risks are managed effectively, and products consistently meet regulatory and quality standards.

Post-Market Surveillance Expertise

Our expertise extends to establishing robust post-market surveillance mechanisms. This involves designing comprehensive strategies for ongoing monitoring of device performance, adverse events, and user feedback. By implementing effective surveillance, we enable timely identification and reporting of any issues, facilitating swift corrective actions and maintaining compliance with regulatory expectations.