||Our strategic partnerships provide extraordinary depth to areas outside our direct expertise and resources:
Reilly & Associates This organization, led by Susan C. Reilly, offers special expertise in regulatory compliance matters involving the FDA Quality System Regulation, European medical device directives, and the Canadian medical device regulations. Services include the following:
- Quality system design and implementation
- Compliance audits
- FDA QSIT and Registrar/Notified Body baseline assessments
Enforcement action (FDA 483, Consent decree, warning letter) strategies and responses
- Agency representation and negotiation
- Compliance certification assessments.
QMS Consulting, Inc.
This company provides consulting services to medical device firms to help achieve Quality System and Regulatory Compliance goals. Sue Jacobs, Principal Consultant, has provided FDA-regulated companies and their global counterparts with her expertise in quality management system development, implementation, FDA inspection readiness, compliance audits, FDA 483 and Warning Letter assistance.
- Developing, implementing, and maintaining quality-system compliance programs including CAPA, Complaint Management, Documentation Control, Internal Audits, Management Controls
- Establishing quality management system infrastructure to support regulated industries
- Quality management system assessments for compliance to FDA regulatory requirements and ISO standards
- Compliance audits, remedial action, organizational assessments
- FDA Enforcement Action, FDA 483 and Warning Letter responses
SCHLUP Consulting GmbH
SCHLUP Consulting provides consulting services and training in quality systems and compliance for medical device firms located in Europe.
MedQ Systems also has supplemental services available from experts in several key disciplines:
- Clinical Affairs
- Biomedical, Mechanical, Electrical, and Industrial Engineering
- Materials Management
- Medical Practitioners
- Microbiology and Sterility Assurance
- Quality and Reliability Assurance
- Regulatory Affairs
- Supplier Management
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