GZP offers a full range of regulatory services for medical device companies. Our strategic regulatory services provide expertise in the overall planning and execution of regulatory compliance through all phases of the device lifecycle. This includes intensive consultation for both interventional (e.g,
Strategic Regulatory Consultation
Plan for Regulatory Compliance Executive and investor briefings, including high-level interactive discussions on key issues associated with the integration of regulatory compliance into product development, approval and marketing programs.
Audit and Assessment
- Conduct independent and objective audits for conformance with medical device regulatory requirements:
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- Quality system audits as required by the Quality System Regulation
- IDE compliance
- Recalls
- Medical device reporting
- Labeling format and content
- Export
- 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:
- Preparation, submission and maintenance of device premarket notification (510(k)) and premarket approval (PMA) submissions.
- Establishment registration and listing:
- GZP assures that client registration and listing is timely and accurate.
- US Agent:
- GZP provides US Agent services for non-US companies intending to market products in the US.
- Investigational Device Exemptions:
- GZP works 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 helps companies proactively develop effective strategies that minimize business and regulatory risks.