Medical Devices Remediation and Compliance Consulting

NSF International provides expert compliance solutions to medical device companies. Our staff of former FDA and EU officials and industry experts combines global regulatory knowledge with industry best practices to help you achieve sustainable and compliant quality systems. Our systems approach ensures that deficiencies are identified and addressed at their root cause, appropriate procedures and metrics are developed and that linkages between the quality subsystems support continuous improvement resulting in sustainable compliance.

Services

NSF International’s services for medical devices regulatory remediation are customized to your specific needs. We approach every client engagement promptly with rigorous project management so that projects are delivered with consistency and accountability. Our services include:

Medical Devices Remediation Strategy, Planning and Execution

• Medical Devices FDA Form 483 and warning letter responses and correspondence
• CE medical device technical file remediation
• Regulatory agency major nonconformity responses
• Corrective action planning
• Import detention and injunction resolution
• Quality system remediation

FDA Third-Party Certification Audits

• Design
• Product quality
• QMS compliance

Compliance Auditing and Gap Assessment

• Baseline assessments
• Due diligence assessments
• Third-party internal audits
• FDA Mock regulatory readiness inspections
• QSIT Audit

Design and Development Support

• DHF development and review

Regulatory Communications and Field Actions

• Field safety notices (FSN)
• Field safety corrective actions (FSCA)
• Recall letters and correspondence
• Patient and user communications

Experts

Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems.

• Gunter Frey, Executive Director, Quality Systems

Success Stories

Challenge: A Fortune 500 medical device manufacturer needed support following an FDA medical devices warning letter.

Solution: NSF Health Sciences Medical Devices provided strategic support and hands-on consultation for a remediation effort covering the seven subsystems of the QSR. As part of this multi-phased approach, NSF Health Sciences Medical Devices led training and coaching sessions for company subject matter experts, developed the remediation program including the creation of a program charter, and built and managed the Program Management Office.

Challenge: A Fortune 500 Class II medical device manufacturer wanted to remove a consent decree.

Solution:  NSF Health Sciences Medical Devices conducted a series of baseline and verification audits, and provided ongoing support following these audits at the facilities and for the products identified in the consent decree.  We also served as the third-party certifier for three separate quality systems certifications as identified in the consent decree.

Challenge: A global medical device manufacturer was facing withdrawal of CE certification for its Class IIb and III products.

Solution: NSF Health Sciences Medical Devices mobilized a team of senior EU regulatory specialists to work in various locations in both the U.S. and UK. NSF acted as intermediaries between several EU competent authorities and the notified body to establish an appropriate action plan to address fundamental regulatory, product validation and quality system deficiencies. NSF coordinated and managed the implementation of regulatory and clinical processes to remediate multiple technical files leading to the successful reissue of CE certification.

Why Work With NSF?

At NSF, we are committed to protecting patient health and safety. Our compliance and remediation services help medical device companies establish quality systems, mitigate risks and achieve sustainable compliance to ensure safe and effective products are available on the market.