Medical Devices
Qualiance can assist you, including:
- Quality System
- Prepare and maintain effective Quality System (Standard Operating Procedures, SOPs) that complies with Medical Devices Regulations (MDL), and simple and flexible enough to support operational excellence
- Quality Assurance and Quality Control including leadership support (short term and long term)
- Set up of Quality Assurance/Quality Control department and provide support to clear any backlogs related to quality system and compliance requirements
- Prepare and maintain Finished Product Specifications to meet the Health Canada requirements
- Deviation, OOS investigations, Incident investigations & CAPA’s
- Product releases as a Quality Control/ Quality Assurance
- Review of product label, batch records, certificates of analysis, finished product release specifications including other applicable records and final product releases
- Review and timely support of batch associated deviations, change controls and CAPAs closure
- Audits
- Quality & Compliance support /Inspections and compliance verifications (remote and onsite) including both pre-Health Canada, post- Health Canada and client or foreign regulatory agency audits
- Host Health Canada, third party, internal audits, or self-inspection program from start to close-out
- Third party audit services
- GAP Analysis, recommendation plan & readiness
- Training, Education & Hiring
- Onsite - Virtual training and education including customized training
- Employees training effectiveness assessment and verification
- Hiring and training of quality and compliance departments key personnel
- Training for compliance remediation
- Validations/Qualifications
- Validations, Verifications & Qualifications of equipment, process and supporting systems(as applicable)
- Effectiveness of cleaning and cleaning validation
- Temperature Mapping and Transportation Validation/Qualifications Studies
- Environment Monitoring Studies
- Review of validations/qualifications protocols/ reports and their assessment
- Supplier/Vendor and Materials management
- Quality management and audits of vendors
- Periodic evaluation and assessment of vendors
- Materials assessment and recommendation
- Pharmacovigilance & Post-market surveillance
- Ensure Good vigilance practices
- Prepare Annual summary report preparation
- Complaints handling, assessment, investigation and recommendation for applicable preventive and corrective actions
- Complaints trending
- Adverse reaction assessment and reporting
- Technical Services
- Quality Assurance and Regulatory Affairs due diligence, Strategic and Technical consulting, and Project Management
- Materials assessments, product development, R&D, and formulations review
- NDA, Quality Agreement, Supply Agreement, Pharmacovigilance, and other technical agreements
- Quality System Documentation/Quality & Continuous Improvements
- Mock recall, recall assessment & management
- Stability studies management, trending, review & assessment
- Annual Product Quality Review
- Risk assessment and management
- Business and process analysis
- Licence maintenance & management
- Medical Devices Establishment Licence (MDEL)
- Medical Device Licence (MDL)
- Medical Devices Establishment Licence (MDEL) Renewal