Services
We provide comprehensive quality, regulatory compliance, and regulatory auditing services and support for medical device manufacturers as well as pharmaceutical and biotechnical firms. At the core of everything we do is the firm belief that quality assurance is a fundamental element of any healthcare-related manufacturing process. Without effective quality control and quality systems it is difficult – if not impossible – to achieve the regulatory compliance necessary to successfully and profitably bring a clinically safe and effective product to market.
To that end, we provide a wide range of services to the medical device, pharma and biotech industries, including:
Regulatory strategy and compliance consulting to medical device manufacturing, biotechnology, and pharmaceutical companies
Auditing to MDSAP, ISO 13485, ISO 9001, 21 CFR 820 and other international regulations and standards to identify any current or potential compliance issues and recommend corrective action
Internal Audits to help ensure regulatory compliance as well as provide an opportunity for self-assessment and overall operational improvements
Startup Assistance and Quality System implementation to create Quality Management System programs, standard operating procedures, and supporting documentation tailored to the client’s needs while ensuring simplified compliance and reduced audit risk
Staffing Support and Services to improve workforce capabilities and performance
Quality System, GLP, GMP gap assessment and improvement to help ensure FDA inspection and audit readiness
Remediation to help your company create and execute quality plans to address gaps in conformance or compliance
FDA Inspection and Audit Readiness and Support to ensure your company is ready to represent the Quality Management System in an upcoming FDA visit or audit
Stability Studies to analyze products for possible degradation over time that could affect performance and lead to functional failure and increased patient risk
Process and Software Validation to ensure processes and software conforms to its intended use, is clinically effective and efficient, presents minimal risk, and is compliant
Supplier Audits and Supplier Quality Evaluation to minimize outsourcing risk in the supply chain as part of an overall quality management system
Risk Analysis to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures
Corrective and Preventive Action (CAPA) program development to help companies investigate and correct quality issues and prevent recurrence
Training to help employees become proficient in all aspects of the Quality Management System
Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition to help manufacturers meet new requirements for selling medical devices in the European Union
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Do you have a quality, compliance, or remediation issue you need help with?