RISK MANAGEMENT & QUALITY MANAGEMENT SYSTEMS
Risk Management and Quality Management Systems (QMSs) are foundations for all life sciences companies. The CRS Team will customize your risk management and quality management systems programs incorporating a proven risk-based methodology that meets the organizational goals, including gap analysis and fully implementing for compliance.
Frequently requested services include:
New Quality System Implementation
Quality systems adapted to your company’s goals considering resources to provide a practical solution for implementation regulation compliance.
- FDA 21 CFR 820
- ISO 13485
- ISO 9001
Improvement of Existing Quality System
Quality systems evolve with growth and often do not adapt, and can become burdensome for organizations to maintain efficiently. CRS provides gap assessments to improve systems efficiency while maintaining compliance to reduce costs. Additionally, implementation of procedure improvements includes resource training and auditing for sustainability.
- Compliance New Regulations
- Gap Analysis
- Risk Assessment
- Management Review
Maintaining an internal audit program is a regulatory requirement. CRS can provide resources to maintain internal monitoring and compliance to your quality system or provide mock audits or inspections in preparation for ongoing audits, unannounced audits, and FDA inspections.
- Internal Audit Services
- Mock Audits and Inspections
- Remediation for Potential Regulatory Deficiencies
Supplier management requires sufficient effort for organizations to maintain, control, and demonstrate compliance. The new MDR regulations require audits for economic operators and critical suppliers. CRS provides supplier services for certifying and maintaining supplier management compliance.
- Supplier and Economic Operator Certification and Auditing
- Supplier and Economic Operator Agreement Support for Unannounced Audits
- Supplier and Economic Operator Nonconformance Remediation Services
- Outsourcing Services
When faced with external audit nonconformances, FDA 483 Inspection Observations and/or Warning Letters, CRS can provide expert support for responding to regulators, from gap analysis to complete response, for quick closure and maintaining full compliance.
- Gap Assessment
- Remediation Mapping and Implementation
- Efficient Communication to Regulatory Entities
New Product Development
Risk-based product development processes are the standard for continued compliance of all regulatory bodies. CRS provides risk analysis of your product development processes and records.
- Gap Analysis and Remediation
- Life Cycle Management
- Design History File
- Technical Documentation and Summary
- Design Reviews
- Gap Analysis of Standards
- Product Deliverables
- Software Risk Assessment (21 CFR Part 11)
- Materials Compliance
- MDR General Safety and Performance Requirements (GSPR) Gap Analysis
- Product Safety Risk Management Compliance (MDR, ISO 14971, ISO/IEC 60601)
- Hazards Analysis, Failure Mode, and Effects Analysis (FMEA), Fault Tree Analysis (FTA)
- Design Transfer
- Design Verification and Validation
Changes in manufacturing processes driven by design or obsolescence can have significant impacts to the operation of an organization. Regulators are looking for continuous improvement processes within the organization. CRS can facilitate risk-based processes demonstrating continuous improvements for dramatic cost reductions and efficiency.
- Gap Analysis and Remediation
- Manufacturing Site Transfer
- Process Validation
Risk-based implementation and support to post-market activities and requirements.
- Post-Market Surveillance Planning and Implementation
- EU MDR Transition
- PMCF – Post-Market Clinical Follow-up
- Data Collection and Analysis
- User Surveys
- Reporting Gap Analysis and Remediation Planning
- Periodic Update and Reporting Services
- Adverse Event and MDR (Medical Device Reporting) Services
- Vigilance Reporting
Data Privacy and Safety
Data privacy and safety is a significant risk for every organization. Protection of company, customer, and patients’ information requires vigilance and ongoing management. The CRS team provides companies and institutions support in these critical areas.
- Review of GDPR and privacy contracts and informed consents
- Select collaboration with law firms and third-party Data Privacy Officers (DPOs) and Data Privacy Representatives (DPRs) to provide support to close gaps of risks
- Developing Privacy/HIPAA/GDPR staff training programs and recording them for future use
CRS Steps in to Help Recalibrate and Conform
An imaging medical device company divested some of their business units which resulted in a significant reduction in force (RIF). To comply with the current EU MDR, Clinical Research Strategies was hired to re-write the company’s clinical SOPs and recalibrate their efforts to conform, while ensuring compliance with multiple global markets (US, Canada, EU and Asia-Pacific). We addressed a major non-conformance and CAPA from a Notified Body audit finding, wrote ten Clinical Evaluation Reports and three Literature Reviews covering over 80 individual devices, trained the Research and Development (R&D) team on the conduct of clinical research studies, assisted with the formal close-out of a forgotten clinical study, and established a single Clinical Evaluation Plan (CEP) for dozens of the legacy device families.
CRS CAN HELP YOU BALANCE RISK WITH COMPLIANCE
Contact us today for a free phone consultation.