Total Product Lifecycle Solutions
from NSF Health Sciences
Medical Devices
Experts in medical device quality systems,
compliance, regulatory affairs, auditing
and training
www.nsf.org
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.
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.
PR
TO
TY
C O N C E PT
O
P R E C LIN I C A L
CE
CL
M ER CIA L US E
COM
OB
SO
LE
S
PE
C
EN
IN
C
I
T IN
MAN
G
AL
U F A C T U RI N G
M
AR
KE
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 +1 202 822 1850.
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
>>>
Clinical-Regulatory Strategy and Submissions
>
Regulatory submissions and support in therapeutic areas
–
–
–
>
Product development documentation development and evaluation
–
–
–
>
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
Training
–
–
>
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
–
–
–
–
–
–
–
–
–
–
>
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
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 20006 USA
Tel: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-701-1113
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
>>>
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
medicaldevices@nsf.org or visit
www.nsf.org
NSF Health Sciences Medical Devices
2001 Pennsylvania Avenue NW, Suite 950, Washington, DC 20006 USA
Tel: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-702-1113
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
>>>
Quality Systems Compliance, Remediation
and Auditing
>
Remediation and compliance support in response to enforcement
action(s)
–
–
–
–
–
–
>
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)
Training
–
–
–
–
–
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
medicaldevices@nsf.org or visit
www.nsf.org
NSF Health Sciences Medical Devices
2001 Pennsylvania Avenue NW, Suite 950, Washington, DC 20006 USA
Tel: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-703-1113
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
>>>
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 20006 USA
Tel: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-704-1113
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.
>>>
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 www.nsf.org
NSF Health Sciences Medical Devices
2001 Pennsylvania Avenue NW, Suite 950, Washington, DC 20006 USA
Tel: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-705-1113
Our People
Experts in Corporate Compliance
lianc
ce and
and Integrity
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: +1 202 822 1850 | medicaldevices@nsf.org | www.nsf.org
LMD-706-1113