Quality Management System

An effective Quality Management System is the foundation for compliance, efficiency, and a quality-driven culture.

An effective Quality Management System (QMS) is central to ensuring any medical device manufacturer's success. We have firsthand experience in developing, implementing, and managing proven QMS programs for a wide range of medical product manufacturers to help you successfully bring your products to the U.S. and international markets and keep them there. Whether you are a one-person start-up or a multi-facility global medical device company, we have the expertise to provide assistance and support.

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We provide a comprehensive portfolio of quality services, including:

• Quality System Audits and Gap Assessments
• Mock FDA Inspections, MDSAP, CE Mark, and ISO Audits
• FDA 483, Warning Letter, Consent Decree, and ISO Observation Response
• Due Diligence
• Supplier Audits
• Interim Quality Professionals
• Remediation Planning and Support
• Post-market Surveillance (PMS)
• Training and Education

Interim Quality Professionals

Are you facing resource constraints in managing Quality internally? Do you have a unique project that your internal team cannot accommodate? Our interim quality professionals are here to assist you, offering cost-effective solutions both remotely and on-site, for as long as you need.

Quality Management Systems

Our seasoned consultants specialize in guiding you through the development and implementation of a comprehensive Quality Management System (QMS), encompassing design, risk management, manufacturing, supply chain, post-market activities, and beyond. We customize your QMS to seamlessly integrate with your company's unique operations and requirements, ensuring optimal performance and compliance.

Auditing

We offer flexible auditing solutions, catering to both on-site and remote needs, or a hybrid approach if limited on-site time is preferred. Our expert team conducts thorough gap assessments and audits, aiding manufacturers like you in fulfilling auditing obligations and pinpointing any compliance disparities amidst the ever-evolving international regulatory landscape.We meticulously evaluate any changes for their implications on your quality system and devices, ensuring seamless alignment with regulatory standards. 

Post-Market Surveillance

Our Post-Market Surveillance (PMS) service diligently collects, documents, and evaluates pertinent data concerning the quality, performance, and safety of your device across its entire lifecycle. This empowers you to consistently refine your risk-benefit assessments and promptly implement any required corrective actions. Particularly crucial for companies penetrating the European Union market, where the Medical Device Regulation (MDR) has undergone substantial revisions pertaining to safety-related device data, our PMS service ensures compliance and enhances product safety standards.

Remediation Services

Has an internal audit revealed substantial system gaps? Have FDA investigators or ISO auditors identified significant non-compliances? Our adept remediation teams collaborate closely with your staff to pinpoint the root causes of these challenges. We engineer pragmatic, impactful, and budget-conscious solutions, implementing measures to align your systems with regulations, and safeguarding your brand's reputation for delivering quality products both presently and in the long term.

Customized Training and Education

With a track record of educating thousands of industry professionals in areas such as design controls, risk management, CAPA, and broader quality systems, we possess the expertise to tailor a training program precisely to your requirements and budget. While our preference lies in providing on-site sessions, in light of the ongoing global COVID-19 pandemic, we're equipped to seamlessly deliver our customized programs remotely, ensuring continuity in your learning journey without compromising on quality or effectiveness.