Empower Your Compliance Journey with Medeq Consulting: Your Dedicated Compliance Engineering Department
At Medeq Consulting, we take pride in offering a comprehensive suite of services, acting as your full-service Compliance Engineering department. Navigating the intricate landscape of compliance investigations, we guide you seamlessly from the initial scoping phase through safety evaluations and beyond.
Here’s a snapshot of the meticulous steps involved in our compliance investigation process:
1. Scoping
- Identifying Safety Standards: Our experts meticulously identify the correct safety standards, including required collateral (if mandated by the chosen certification scheme) and particular standards.
- Certification Scheme: We help you pinpoint the most suitable certification scheme for your product.
2. Preliminary Review
Construction Review:
- In-depth examination of production-ready samples.
- Mapping out required electrical insulation barriers.
- Comparison of construction against the Bill of Material (BOM).
- Cross-referencing construction against production drawings.
- Review of critical components for safety compliance.
- Identifying additional standards based on construction characteristics.
Documentation Review:
- Assessment of Essential Performance and the product’s intended use.
- Thorough review of design documentation, including label artwork, electrical schematics, and product drawings.
- Scrutiny of User/Technical Support Manuals.
- Evaluation of ISO 14971 Risk Management Documentation.
- Review of ISO 13485 Quality Management System Requirements for regulatory purposes of Medical Devices.
- Assessment of IEC 62304 Software Life Cycle Process for Medical Devices.
Planning:
- Development of a safety test plan.
- Creation of Draft Test Report Forms (TRFs).
- Mitigation of compliance issues.
Safety Evaluation:
- Serving as your Agent in supporting Safety Submissions with third-party test laboratories.
- Effective Project Management.
- Resolving compliance issues promptly.
3. Follow-Up Services
- Under OHSA’s NRTL program, we guide you through the intricacies of changes to the device construction, labeling, or documentation covered by the NRTL mark.
- Ensuring that any modifications, no matter how seemingly immaterial, are communicated to your NRTL to safeguard the integrity of the safety mark.
OUR COMPLIANCE EXPERIENCE
Embark on your compliance journey with confidence, knowing that Medeq Consulting is your dedicated partner throughout. Our commitment is to streamline the compliance process, address potential challenges and ensure your product not only meets safety compliance standards but also gives you peace of mind the patient at the receiving end of your device has an effective and safe healthcare experience. Partner with us for a compliance experience that goes beyond expectations.