||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.
Malloy & Associates
The company, established in 1987 by Mr. John J. Malloy, provides consulting, training, planning and auditing services to the medical device industry in the areas of U.S. Food and Drug Administration (FDA) regulatory compliance and ISO quality systems. Clients are both domestic and international, ranging in size from start-ups to Fortune 100 companies. The company strives to assist companies in the establishment of a quality system that is an asset to the organization and meets regulatory requirements as a byproduct.
Examples of the types of services provided include:
- 21 Code of Federal Regulations, Part 820 Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) and ISO 9001/13485 audits and consultations to assist companies in meeting FDA and European Medical Device and IVD Directive requirements and to provide due diligence information as part of merger agreements.
- Design and conduct QSR/GMP, ISO 9001/13485, design control, corrective and preventive action, auditing, process validation and software development seminars.
- Certification that a company operating under a consent decree is ready for an FDA follow-up inspection.
- Assist companies in the definition and implementation of corrective actions in response to FDA inspections and warning letters.
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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