IMPLEMENT CONTINUOUS QUALITY IMPROVEMENT AND VIGILANCE FOR YOUR PROGRAMS

Mitigate the Risk to Your Stakeholders

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
MDR
MDSAP
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
Implementation
Management Review
Training

Internal Audits

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

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

Remediation

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

Manufacturing Improvement

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
Training

Post-Market Surveillance

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.

THE COST OF POOR QUALITY

Who are you kidding when you pick cheap or fast as your primary decision-driver? Are you really saving time and money in the long run? CRS has numerous lessons learned to share with our clients when corners are cut. Quality Assurance, Customer Satisfaction, Service and Sustainability are inextricably linked. Let us be your sounding board for maximizing a culture of quality that works for your business.

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