Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices

Transcription

1 Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Experts in medical device quality systems, compliance, regulatory affairs, auditing and training

2 The Right People. The Right Solution. The First Time. Medical device companies operate in a complex global regulatory environment with continually changing standards. NSF Health Sciences has a team of experts in the regulatory, scientific, analytical testing and compliance fields that understands the industry and regulatory requirements to bring medical devices to market and sustain them throughout their lifecycle. NSF Health Sciences Medical Devicea services can assist companies in navigating U.S. and international regulatory hurdles from product inception through product marketing.

3 Comprehensive Services NSF Health Sciences Medical Devices provides these services: > Quality systems implementation, remediation, compliance and assessment > Inspection readiness and mock audits > Regulatory strategy / clinical support and submissions > Corporate compliance program design, implementation and sustainment > Training and education NSF Health Sciences Medical Devices maintains a commitment to outstanding service and quality, and focuses on achieving the client s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs. PROTOTYPE CONCEPT OBSOLESCENCE PRECLINICAL COMMERCIAL USE CLINICAL MARKETING MANUFACTURING

4 The Right People. The Right Solution. The First Time. NSF Health Sciences Medical Devices provides international regulatory consulting services including FDA and EU expertise to support the development, marketing, and stewardship of medical devices, including in vitro diagnostics and combination products. Our core expertise is the design and implementation of successful efforts to resolve, or avoid, challenges posed in the development of new, innovative products. We work with a network of subject-matter experts, across all therapeutic areas, to provide our clients with appropriate expertise in any field. In all of our assignments, we work to balance complying with the regulatory requirements with our clients business needs. For more information about NSF Health Sciences Medical Devices and our services, please contact us at medicaldevices@nsf.org or call

5 Clinical-Regulatory Strategy and Submissions NSF Health Sciences Medical Devices provides international regulatory consulting services including FDA and EU expertise to support the development, marketing and stewardship of medical devices, including in vitro diagnostics and combination products. Our core expertise is the design and implementation of successful efforts to resolve, or avoid, challenges posed in the development of new, innovative products. In addition to our consultants, who bring FDA and industry expertise to your projects, we work with a network of subject-matter experts, across all therapeutic areas, to provide our clients with the utmost quality and expertise in any field. In all of our assignments, we seek to balance complying with the regulatory requirements with our clients business needs. NSF Health Sciences Medical Devices regulatory team provides a range of specific services to meet all of your regulatory needs across the product development and marketing continuum. > Strategic consultation Regulatory strategy: product classification, submission type, predicate device recommendations, applicable standards and guidance documents Emerging regulatory issues: mobile medical applications, combination products Due diligence >>>

6 Clinical-Regulatory Strategy and Submissions > Regulatory submissions and support in therapeutic areas Pre-market submissions: IDE, 510(k), de novo, PMA, amendments, technical file/design dossier for European CE marking Post-marketing submissions: PMA supplements, 510(k)s for changes, annual reports and post-market studies Responses to submission deficiency letters and additional information requests > Product development documentation development and evaluation Preclinical testing: safety and performance testing plans, protocols and reports Risk analysis: dfmea, pfmea, fault tree analysis and safety assurance cases Design and development plans and traceability matrices > FDA and European agency interactions > Training Informational, pre-submission and submission issue meetings Competent authority scientific briefings Advisory panel preparation and support* Dispute resolution and administrative appeal Clinical study design and evaluation and SR/NSR determinations Patient population identification and endpoint selection Protocol development support Statistical analysis plans Report, manuscript and publication development Human factors evaluations and labeling comprehensions studies FDA and EU classification of medical devices CE marking and U.S. marketing authorization pathways > Global regulatory filings and global strategies NSF Health Sciences Medical Devices 2001 Pennsylvania Avenue NW, Suite 950, Washington, DC USA Tel: LMD

7 Corporate Compliance and Integrity Programs NSF Health Sciences Medical Devices is expanding its service offerings to provide consulting, auditing and training to support the effectiveness of compliance programs as established by the Health and Human Services Office of the Inspector General (OIG). The NSF Health Sciences Medical Devices Corporate Compliance and Integrity Programs group brings you a team of former industry compliance executive and management professionals with over 25 years of experience in the pharmaceutical and medical device industries. The NSF team assists clients in the development, implementation and continuous improvement efforts of ethics and compliance programs. Using tested strategies to mitigate risk through collaborative efforts, we can support the business and compliance needs of your entire organization. The broad range of services includes: > Strategic consultation Compliance program design, implementation and sustainment (including gap analysis of existing compliance programs) > Federal health care programs fraud and abuse prevention training > Corporate Integrity Agreement compliance support > Internal review organization services > Board of directors compliance expert services >>>

8 Corporate Compliance and Integrity Programs Services continued: > Clinical, commercial and post-market activities auditing and monitoring > Internal and external investigation support > Open payments reporting > Anti-bribery and expert controls counseling > Auditing and monitoring of sales force For more information, contact or visit NSF Health Sciences Medical Devices 2001 Pennsylvania Avenue NW, Suite 950, Washington, DC USA Tel: LMD

9 Quality Systems Compliance, Remediation and Auditing NSF Health Sciences Medical Devices services in compliance and quality systems provide business-forward compliance solutions to our clients. Our staff of former FDA and EU officials as well as industry experts allows us to combine global regulatory knowledge with industry best practices to help our clients achieve a compliant quality system that is right for their business. We utilize a systems approach to ensure deficiencies are identified and addressed at their root cause, appropriate procedures and metrics are developed, and that linkages between the quality subsystems support a continuous improvement process for sustainable compliance. We provide these services in core compliance and quality systems: > Third-party GxP system-based gap analyses Targeted deep dive assessments Mock FDA inspection and FDA-readiness support (QSIT approach) Due diligence assessments Mock European regulatory agency audits > Quality systems implementation and development Metric development, compliance scorecards and dashboards Coaching and mentoring Project management Reengineering and process mapping SOP writing QS software evaluation, SDLC requirements and postimplementation assessments >>>

10 Quality Systems Compliance, Remediation and Auditing > Remediation and compliance support in response to enforcement action(s) > Training Corrective action plans development and implementation FDA 483 and warning letter responses Injunctions (consent decree) Recalls and import detentions AIP resolution Corporate Integrity Agreements (CIA) 21 CFR 820 Quality System Regulation 21 CFR 803 Medical Device Reporting 21 CFR 806 Corrections and Removals Audit readiness Quality system subsystem-specific training sessions including; CAPA, management review, design control and risk management For more information, contact or visit NSF Health Sciences Medical Devices 2001 Pennsylvania Avenue NW, Suite 950, Washington, DC USA Tel: LMD

11 International Services: European Expertise NSF Health Sciences Medical Devices has European based experts that support our clients in their CE Marking and European Medical Device Training needs. Our experts have extensive professional experience in both European Regulatory agencies (Competent authority and Notified body) and EU regulated industry. Our Services Include: Regulatory and Clinical Services > European regulatory body interactions > CE Marking expertise including classification decisions and competent authority briefings > European Clinical Trial Design, Investigation and Clinical Evaluations > Technical file/ design dossier development and review including Regulatory Science Expert reports Quality Systems and compliance > ISO13485 Quality System Implementation > Notified body audit preparation > Supply Chain approval as part of a CE marked device > CE Marking and ISO13485 audits > EU safeguarding and Notified body CE marking withdrawal remediation Training and Medical Device QARA professional qualifications > Company-Wide Quality and Regulatory awareness modules > Professional Certificates and Post-Graduate Qualifications in Quality Assurance and Regulatory affairs > Lead and Internal Auditing training program > Industry and Regulator focused Study days covering a range of Regulatory, Quality and Medical Device professional topics >>>

12 Our People James Pink Vice President, Europe Mr. Pink has 16 years experience in the medical devices industry including 10 years as a HealthCare Technology Expert and Lead Auditor for a leading European Notified body. His industry experience includes managing development and quality assurance programs for Orthopedic, Cardiovascular, Wound and Combination products. He has a team of experts based in Europe who have over 20 years individual experience in both Competent Authority and Notified body leadership. James has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings as well as EU remediation strategies. Yvonne Middlefell, BA Hons RAC FRAPS Executive Director Ms. Middlefell leads our European Regulatory Strategy and Clinical services having extensive experience in Global Medical Device Regulatory Affairs. She has worked for a number of key multinational corporations. These include Amersham Nycomed, Eastman Kodak, Bausch and Lomb and a 25 year tenure at Johnson and Johnson. Her RA experience includes developing Global Regulatory strategies for IVD s, Medical Devices, OTC products, Biologics and Pharmaceuticals. Ms. Middlefell has written and filed multiple CE Technical files and US 510(k) s for a range of products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses and solutions. In addition she has successfully managed a full PMA for an IVD US product submission. She was her company s primary interface with regulatory agencies and industry bodies such as AdvaMed (USA) and EDMA (EU). NSF Health Sciences Medical Devices 2001 Pennsylvania Avenue NW, Suite 950, Washington, DC USA Tel: medicaldevices@nsf.org LMD

13 Our People Experts at NSF Health Sciences Medical Devices 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 the U.S. 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. Timothy Ulatowski Vice President, Regulatory & Compliance Timothy Ulatowski has over 36 years of public health experience, including more than 20 years in multiple leadership positions at the U.S. 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 pre-market documents and resolving complex technical and scientific problems. >>>

14 Our People 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 handson 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 within the healthcare sector. James Pink Vice President, Europe Mr. Pink has 16 years experience in the medical devices industry including 10 years as a HealthCare Technology Expert and Lead Auditor for a leading European Notified body. His industry experience includes managing development and quality assurance programs for Orthopedic, Cardiovascular, Wound and Combination products. He has a team of experts based in Europe who have over 20 years individual experience in both Competent Authority and Notified body leadership. James has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings as well as EU remediation strategies. For more information, contact medicaldevices@nsf.org or visit NSF Health Sciences Medical Devices 2001 Pennsylvania Avenue NW, Suite 950, Washington, DC USA Tel: medicaldevices@nsf.org LMD

15 Our People Experts in Corporate Compliance and Integrity at NSF Health Sciences Francisco Rivas, Esq. Vice President, Corporate Compliance & Integrity Programs Mr. Rivas has over 25 years of experience in senior roles in the pharmaceutical and medical device industry, where he has provided counseling and guidance on compliance and risk management of commercial, quality and clinical issues. He has negotiated with or presented to U.S. FDA advisory committees as well as the FDA and Office of Inspector General (OIG) on issues pertaining to his clients. Most recently, Mr. Rivas was Vice President and Chief Compliance Officer for a medical device company under a Corporate Integrity Agreement (CIA) with the OIG. Katie Norris Director, Compliance & Integrity Programs Ms. Norris has over 10 years of experience in corporate governance and compliance in the pharmaceutical, medical device, OTC consumer products and cosmetics industries. She has performed substantial internal investigations and supported extensive federal investigations with multiple agencies including the U.S. Department of Justice, Health and Human Services Office of Inspector General and the Securities and Exchange Commission. Ms. Norris assists clients with internal and external investigations; remediation of cross functional compliance concerns (including implementation and compliance with CIAs & DPAs); and the operational aspects of compliance program development, management and oversight, including aggregate spend initiatives. NSF Health Sciences Medical Devices Tel: medicaldevices@nsf.org LMD