Quality Systems and Compliance

  • Overview
  • Services
  • Experts
  • Success Stories

NSF Health Sciences provides expert compliance solutions. 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.

For more information about NSF medical device quality systems implementation, remediation and auditing in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about NSF medical device quality systems implementation, remediation and auditing in Europe, email eudevices@nsf.org or call +44 1143 600 868.

Services

NSF Health Sciences offers a wide variety of quality systems implementation, remediation and auditing services, including:

Remediation and Compliance Support in Response to Enforcement Action(s)

  • Third-party reviews, assessments and certifications
  • Corrective action plan development and implementation
  • FDA 483 and warning letter responses
  • Injunctions (consent decrees)
  • Recalls and import detentions
  • AIP resolution
  • Corporate Integrity Agreements (CIA)

Quality Systems Regulation/Good Manufacturing Practices (GMPs)

  • Targeted “deep dive” assessments
  • Mock FDA inspection and FDA-readiness support (QSIT approach)
  • Due diligence assessments
  • Mock European regulatory agency audits

Quality Systems Design and Implementation

  • Metric development, compliance scorecards and dashboards
  • Coaching and mentoring
  • Project management
  • Reengineering and process mapping
  • SOP writing
  • QS software evaluation, SDLC requirements and post-implementation assessments

Training Services

  • General cGMP training on 21 CFR Part 820 Medical Devices as well as 21 CFR Part 809 In Vitro Diagnostic Products
  • Specific training modules (not all inclusive)
    • Management responsibilities
    • CAPA
    • Design control and risk management

Design Control and Risk Management

  • CAPA and complaints
  • Medical events reporting  (21 CFR Part 803)
  • Supplier quality/purchasing control
  • Workshop(s)  e.g. on root cause analysis

International Services

  • ISO 13485 quality system implementation
  • Notified body audit preparation
  • Supply chain approval as part of a CE marked device
  • CE marking and ISO 13485 audits
  • EU safeguarding and notified body CE marking withdrawal remediation

Good Clinical Practice/Bioresearch Monitoring (BIMO)

  • Institutional Review Board (IRB) support
  • Sponsor/monitor audits
  • Clinical investigator audits
  • Clinical data integrity verification

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.

Elaine Messa, RAC, FRAPS - President Health Sciences Medical Devices

Elaine Messa has over 30 years of experience in FDA regulation of medical devices, focused on the development and implementation of compliance quality systems for medical devices in the United States and abroad.  Her most recent position at FDA was Director of the Los Angeles District. Ms. Messa has significant experience in auditing, agency communication, development of quality systems, and design and implementation of corrective action plans to address complex compliance situations including consent decrees, Corporate Integrity Agreements, warning letters and 483s.

Mary C. Getz, Ph.D. - Vice President, Quality Systems & Compliance

Dr. Getz has over 25 years of industry experience, including extensive expertise in developing quality, compliance and regulatory affairs strategies and solutions. She has helped domestic and international manufacturers to develop and implement comprehensive compliance action plans. The results were effective quality systems which lead to successful FDA and notified body inspections as well as NDA and PMA product approvals. Dr. Getz has hands-on experience with IVDs, 510(k) and PMA medical devices, as well as OTC and NDA pharmaceuticals.  She has held vice president-level roles in quality and regulatory affairs at numerous multinational companies in the healthcare sector.

Timothy Ulatowski - Expert Consultant

Timothy Ulatowski has over 36 years of public health experience, including more than 20 years in multiple leadership positions at FDA’s Center for Devices and Radiological Health (CDRH). He most recently served as Director of the Office of Compliance at CDRH, where he managed and supervised four divisions responsible for ensuring compliance with medical device regulations. Mr. Ulatowski has proven expertise in advising industry on regulatory issues, assessing compliance and enforcement actions, evaluating premarket documents, and resolving complex technical and scientific problems.

Success Stories

Challenge:  A Fortune 500 medical device manufacturer needed support following an FDA 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 lead 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 consulting 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.

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