Medical Device Quality Management Systems (QMS) Consulting
An effective Quality Management System (QMS) is central to ensuring any medical device manufacturer's success, as well as the foundation for compliance, efficiency, and a quality-driven culture. 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 aid and support in medical device quality consulting and ISO 13485 consulting.
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
Our Quality Consulting Services
Our quality services are tailored to meet your specific needs and may include:
Interim Quality Professionals
Quality Management Systems
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 medical device manufacturers in fulfilling auditing obligations and pinpointing any compliance disparities amidst the ever-evolving international regulatory landscape. We meticulously evaluate any changes to understand 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 entering 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-compliance? 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 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, we're equipped to effectively deliver our customized programs remotely for continuity in your learning journey
Contact MEDIcept for Medical Device QMS Consulting
How can we help you? Fill out the form below to get assistance from our expert team with remediation, auditing, warning letters, training, and more. A member of our team will contact you within the next 1-2 business days.
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