QualityAn 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 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 can have the expertise to provide assistance and support.
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
Do you lack the resources to handle Quality in-house? Have a special project that you can’t staff with your internal team members? Our interim quality professionals can support your needs in a cost-effective manner, both remote and on-site, for as long as you require.
Quality Management Systems
Our team of experienced consultants can help you develop and implement a Quality Management System covering all aspects of design, risk management, manufacturing, supply chain, post-market activities, and more. Your QMS will be tailored to work for your company.
On-site and remote auditing services. Or a hybrid combination if on-site time is necessary, but you opt to keep it limited. We perform gap assessments and audits to assist manufacturers like you in meeting auditing commitments and identifying any compliance gaps between your systems and the constantly-changing international regulatory requirements. We ensure that any changes are assessed for their impact on both your quality system and your devices.
Post Market Surveillance
Our PMS service gathers, records, and analyzes relevant data on the quality, performance, and safety of a device throughout its lifecycle, enabling you to continuously update the risk-benefit assessment and quickly initiate any necessary corrective measures. This is especially important for companies selling into the European Union, where MDR regulations have changed significantly regarding safety-related device data.
Did an internal audit uncover significant system gaps? Did an FDA investigator or ISO auditor find significant non-compliances? Our highly experienced remediation teams work hand-in-hand with your employees to uncover the root cause of these issues, develop practical, effective, and cost-efficient solutions, and implement the necessary measures to bring your systems into compliance to safeguard brand reputation for quality products now and in the future.
Customized Training and Education
We have trained thousands of industry professionals in design controls risk management, CAPA, general quality systems, and so much more! We can custom-tailor a training program to fit your specific needs and budget. And while we love being on-site, with our current worldwide COVID-19 pandemic, we can offer our custom programs for remote delivery.
I need help NOW!
Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.
Are you facing an FDA inspection?
Are you facing an FDA inspection or ISO audit? Don’t go it alone. Our knowledgeable team with first-hand experience will help you prepare with confidence.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective QA and regulatory compliance strategies to obtain FDA and ISO clearances. We’ll work with you to implement a quality system appropriate to the growth stage of your company.