Regulatory & Compliance Consultant
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Consulting Intervention
The consulting firm initiated a meticulous gap analysis, identifying discrepancies between the existing system and MDSAP requirements. As shown below, we developed about 33 procedures for the client. For each of these procedures, the scope was very well defined and the process was such that it would mimic the actual operations of the company.
- Quality Manual: To document the structure of QMS in an outline.
- SOP for Document Control: To address MDSAP requirements for control of documents.
- SOP for Record Control: To address MDSAP requirements for control of quality records.
- SOP for Hiring and Training: To establish a systematic process for hiring personnel and providing training.
- SOP for Management Review: To establish a procedure for performing management reviews.
- SOP for Quality Audit: To establish a procedure for performing quality audits.
- SOP for Process Risk: To ensure a process for risk assessments on processes.
- SOP for Data Analysis: To establish a process and techniques to be followed for data analysis and statistical techniques.
- SOP for Process Validation: To address the MDSAP process validation requirements.
- SOP for Design Control: To address the MDSAP design control requirements.
- SOP for Risk Management: To address the MDSAP risk management requirements.
- SOP for Engineering changes: To define the change control process.
- SOP for DHF, DMR, and DHR: To establish a procedure for covering DHF, DMR, DHR requirements.
- SOP for Production Planning and Control: To establish a procedure for production processes.
- SOP for Control of Monitoring and Measuring Devices: To define a process for control and maintenance of measuring equipment and monitoring devices.
- SOP for Testing Activities: To define a process for testing activities performed.
- SOP for Nonconforming Product: To define a process for managing non-conforming products before and after delivery.
- SOP for Supplier selection: To define supplier selection, and evaluation criteria.
- SOP for Purchasing: To define purchasing process.
- SOP for Sales and Distribution: To define sales and distribution process.
- SOP for Handling, Storage, and Transportation: To define the handling, storage and transportation criteria.
- SOP for Complaint Handling: Establishing a robust system with real-world examples and simulations for staff training.
- SOP for Corrective Action and Preventive Action: Ensuring systematic problem-solving and preventive measures.
- SOP for Regulatory Compliance: To define the regulatory requirements per MDSAP.
- SOP for Adverse Event Reporting: To define regulatory reporting requirements per MDSAP.
- SOP for Incoming Inspection and Final Inspection: To define inspection of incoming and final goods activities.
- SOP for Identification and Traceability: To define traceability of device throughout its lifecycle.
- SOP for Labeling and Packaging: To define the labeling and packaging requirements.
- SOP for Biological Safety and Infection Control: To establish a process for ensuring biological safety and control infections.
- SOP for Work Environment and Infrastructure Management: To ensure maintenance of work environment and infrastructure.
- SOP for Clinical Performance Evaluation: To establish a procedure to assess clinical performance of the device.
- SOP for Post-Market Activities: To define the post-market activities of the device.
- SOP for Emergency Handling: To establish a procedure to be followed in case of emergencies such as flood.
They introduced tailored procedures, including:
- Risk Management Protocol: To address MDSAP requirements for comprehensive risk assessments.
- CAPA (Corrective and Preventive Action) Framework: Ensuring systematic problem-solving and preventive measures.
- Complaint Handling Mechanism: Establishing a robust system with real-world examples and simulations for staff training.
The consulting firm guided the company in establishing a proactive complaint handling procedure. Real-world examples and simulations were integrated to enhance staff understanding. This proactive approach aimed to preemptively address potential issues, aligning with the MDSAP framework.
Leveraging their expertise, the consulting firm streamlined the MDSAP certification process. They facilitated communication with auditors, ensuring seamless compliance. Their involvement significantly reduced the certification timeline, allowing the company to proceed swiftly.
- Proactive Procedures: Tailoring procedures to regulatory nuances is crucial. The complaint handling procedure, when implemented proactively, acts as a preemptive regulatory shield.
- MDSAP as a Catalyst: MDSAP certification not only ensures compliance with multiple jurisdictions but can expedite overall regulatory approval processes.
- Expert Guidance Matters: Engaging a consulting firm well-versed in MDSAP intricacies ensures a smoother journey. Their real-world examples and targeted interventions save both time and resources.
In this success story, the confluence of regulatory expertise and proactive quality management resulted in swift MDSAP certification, opening doors to both Health Canada and the FDA. The case exemplifies the paramount importance of strategic partnerships in the dynamic landscape of global medical device compliance.
Client Background
In the fast-paced landscape of medical device development, a visionary point-of-care COVID testing device company sought regulatory approval from Health Canada and the FDA. Recognizing the complexity of international markets, they partnered with a specialized consulting firm to streamline their quality management system.
Challenges
The company faced dual challenges of meeting Health Canada's stringent requirements and aligning with the FDA's quality system regulations. Their existing system lacked the harmonization required for both regions, and a comprehensive overhaul was essential.
