Medical Devices

GZP offers a full range of regulatory services for medical device companies. Our strategic regulatory consultation services provide expertise in the overall planning and execution of regulatory compliance through all phases of the device lifecycle. We also offer a variety of regulatory services including preparation, submission and maintenance of device premarket notification and premarket approval applications, US Agent services, registration and listing services; and expert assistance in establishing Medical Device Reporting, recall, and other programs that are effectively integrated with quality systems and other existing programs. GZP also offers objective and independent auditing and assessment services to help manufacturers evaluate and improve their quality systems and other regulatory compliance systems.

Strategic Regulatory Consultation

Planning for Regulatory Compliance Executive and investor briefings. This includes high level interactive discussions on key issues associated with the integration of regulatory compliance into product development, approval and marketing programs.

Assessment

GZP can conduct independent and objective audits for conformance with medical device regulatory requirements, including quality system audits as required by the Quality System Regulation. Other assessment areas include IDE compliance, recalls, medical device reporting, labeling format and content, and export. GZP can assess existing regulatory compliance systems and processes to identify deficient, unnecessary, inconsistent, and redundant activities and make recommendations to streamline compliance programs..

Regulatory Services

Premarket submissions – GZP can provide expert consultation in the preparation, submission and maintenance of device premarket notification (510(k)) and premarket approval (PMA) submissions. GZP combines well-researched, complete, concise, “reviewer friendly” submissions with effective FDA communications and negotiation to facilitate marketing clearances and approvals.

Establishment registration and listing – GZP can assure that client registration and listing is timely and accurate.

US Agent – GZP can provide US Agent services for non-US companies intending to market products in the US.

Investigational Device Exemptions – GZP can work with clients to establish effective IDE programs necessary to support marketing approvals.

Medical Device Reporting – GZP assists its clients in developing conforming MDR programs that are effectively integrated with client quality systems and other regulatory requirements.

Recall Strategy Development – GZP can help companies proactively develop effective strategies that minimize business and regulatory risks.