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Associate Members

 

Associate Members

Law Firms

Akin Gump Strauss Hauer & Feld LLP

Hooper, Lundy & Bookman, PC

King & Spalding

McAndrews, Held & Malloy

Reed Smith LLP

Sidley Austin LLP

Business Intelligence

IQVIA

Insurance

Medmarc

Supply Chain Management

FedEx Services

Quality Management

MasterControl Inc.

Consulting Groups

Accenture

China Med Device, LLC

Cognizant Technology Solutions

Deloitte

L. E. K. Consulting LLC

IQVIA

MIDI Medical Device Development Corp.

North American Science Associates, Inc.

Porzio Life Sciences, LLC

QAD

Regulatory and Quality Solutions LLC

 

 

 

Akin Gump Strauss Hauer & Feld LLP

Akin Gump Strauss Hauer & Feld LLP is a leading international law firm. From capitalization through postmarket representation, health care policy and legislative strategy, we work with clients to ensure that their global regulatory strategies and legislative interests are aligned to maximize opportunities for coverage and reimbursement, entry into new markets and further research and development.

Contact: Nathan A. Brown, Partner, Akin  Gump Strauss Hauer & Feld LLP

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Accenture

Accenture is a global management consulting, technology services and outsourcing company, with more than 358,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$31.0 billion for the fiscal year ended Aug. 31, 2015.

Contact: Doug Mowen, Managing Director

View our white papers

Disrupt or Be Disrupted: Prescriptions for life sciences in the age of digital medicine

Accenture Technology Vision 2015 for Life Sciences

Patient Services: Pharma’s Best Kept Secret

Breaking free from the cost-cutting cycle in the life sciences industry

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China Med Device LLC

China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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Cognizan

Cognizant's Life Sciences practice is committed to helping change millions of lives for the better by partnering with clients to build solutions to healthcare challenges, continually improve the way they do business, set the pace in clinical development, strengthen their regulatory infrastructure, and increase competitiveness. Cognizant serves 28 of the top 30 global pharmaceutical companies, 9 of the top 10 biotech companies, and 12 of the top 15 medical device companies.

Contact: Sriraman Nagajaran, Associate Vice President & SBU Head, Life Sciences

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Deloitte

Deloitte’s life sciences and health care industry group is composed of more than 7,300 professionals in over 90 countries. We understand the complexity of today’s life sciences industry, including the journey to redefine patient-centric care, innovate, and grow, and can help clients through the challenges that each part of the journey can bring. Our professionals are backed by a global organization whose tools, industry-wide experience, and knowledge are aligned to help companies see what’s in front of them and what’s ahead. Our team can pull together the resources and cross-discipline capabilities to help formulate the right strategy and turn it into reality.

Contact: Lynn Sherry, Senior Marketing Manager Life Sciences

View our white papers

Six future roles for medtech companies in the future of health

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Connecting people with goods, services and ideas creates opportunities and improves lives. FedEx believes that a connected world is a better world, and that belief guides everything it does.

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Hooper, Lundy & Bookman, PC

Hooper, Lundy & Bookman, PC (HLB) is the largest law firm in the country dedicated solely to representing providers of health care products, services and technology. With offices in Boston, Los Angeles, San Diego, San Francisco, and Washington, D.C., HLB has clients in all 50 states who turn to us for their most significant matters, including investigations, transactions, regulatory reviews, and high-stakes litigation. HLB has developed a generation of attorneys specialized in the health care, health-tech and the life sciences industries. HLB’s size and specialization enable us to represent our clients in every aspect of their health care and med-tech needs, from counseling on day-to-day issues to their largest and most complex matters. We are recognized by US News/Best Lawyers as a Tier 1 (National) firm in Health Care Law and by Chambers USA for our national and regional expertise in Health Care Law.

Contact: Drew Woodmansee, Esq., Partner, 619.744.7303

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King & Spalding

Celebrating more than 130 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with over 1100 lawyers in 20 offices in the United States, Europe, the Middle East and Asia. King & Spalding knows the medical device industry—the technologies, products and business models. Our attorneys and consultants provide sophisticated counsel to our medical device clients —including many of the best known names in the industry — in a wide range of areas, including fraud and abuse, compliance, intellectual property, regulatory, transactional, policy and litigation matters. We are a premier firm ranked by Law360 (Life Sciences “Practice Group of the Year” in 2016-2018), U.S. News & World Report (“Law Firm of the Year” for FDA Law in 2017), LMG Life Sciences, Chambers USA and The Legal 500.

Contact: Mark Brown, Partner, 202.626.5443

White papers/reports

King & Spalding's FDA & Regulatory Client Alerts

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L.E.K. Consulting

L.E.K. Consulting is a global management consulting firm that uses deep industry expertise and rigorous analysis to help business leaders achieve practical results with real impact. We are uncompromising in our approach to helping clients consistently make better decisions, deliver improved business performance and create greater shareholder returns. The firm advises and supports global companies that are leaders in their industries — including the largest private and public sector organizations, private equity firms and emerging entrepreneurial businesses. Founded more than 30 years ago, L.E.K. employs more than 1,000 professionals across the Americas, Asia-Pacific and Europe. 

Contact: Megan DeNovellis, Marketing Coordinator

View our white papers

What’s Next for U.S. Healthcare Under Trump?

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MasterControl

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

Contact: info@mastercontrol.com, 866-747-8767

View our resources:

The Ultimate Guide to Digitizing the Shop Floor

Carestream Health Case Study

Recent webinars:
Manufacturing Technology: Features and Functionality for Changing Environments

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McAndrews

McAndrews, Held & Malloy is a premier, full-service intellectual property and technology law firm. From world-class patent portfolio development, trademark, and design protection to its exceptional record of litigation success against highly regarded law firms, McAndrews excels at all things IP. That is why the firm is relied upon by industry-leading companies, as well as businesses and innovators of all sizes and in virtually every technical field. McAndrews is also uniquely positioned and structured to serve clients efficiently and effectively, providing exceptional lawyers, insights, service, and value.

Contact: David Schulte, Head of Marketing
Email: dschulte@mcandrews-ip.com
Phone: 312-775-8000

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Medmarc

Industry specific insurance and related risk management solutions

Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve.  From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me to discuss the cost of insurance coverage, what coverages are needed and when for your business plan. 

Contact: George Ayd, (703) 652-1309

View our white papers

UDI Fundamentals, Ask an Expert

What are the best practices for dealing with FDA inspections?, Ask an Expert   

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MIDI logo

MIDI is Expert in Medical Innovation.

MIDI Medical Device Development Corp. is a full-service FDA & ISO compliant Medical Device Development Consulting Firm with 45 years experience serving clients in the medical, life sciences & home healthcare markets. MIDI's teams of research, design and engineering professionals offer a unique combination of talent, experience and achievement developing Class I,II & III devices. From the first idea to the last detail, we balance technical information with strong orientation toward user driven design solutions. Our prime goal is total satisfaction for the clients we serve.

Contact: Christopher Montalbano, Co-founder & CEO
Phone: 631-467-8686

View our white papers

MIDI’s Innovation Vault

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NAMSA

NAMSA is leading contract research organization, and the world’s only medical research organization, providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.

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Porzio Life Sciences is dedicated to helping pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment.  We enhance the marketing and sales programs of a range of companies:

  • Pharmaceutical and Medical Device Manufacturers and Distributors
  • Virtual Pharmaceutical Companies
  • Contract Sales Organizations
  • Vendors to Life Sciences Industry
  • Wholesale Distributors and Labelers

Contact: Tuyet Dorr, Marketing & Client Services Manager
Contact’s email: ttdorr@pbnlaw.com

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QAD logo         

QAD is a leading provider of flexible, enterprise software for global manufacturing companies. QAD’s flagship product, QAD Adaptive ERP, reflects a four-year long research and development effort to transform QAD’s ERP to make it easier for customers to rapidly adjust to these disruptive times in manufacturing.

Because QAD only focuses on six sectors within manufacturing, life sciences being a dominate one, QAD Adaptive ERP offers excellent fit out-of-the-box versus more general ERPs. Manufacturers that want to take advantage of advanced technologies and industry disruption need an ERP with the agility to help them stay ahead. QAD Adaptive ERP’s application platform, QAD Enterprise Platform, includes several cloud-era technologies that support a rapid response to change, ensuring future fit.

For more information, please contact QAD at +1-805-566-6100 or email info@qad.com.

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Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, IQVIA continuously invests and commits to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.

IQVIA is inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology, and human intelligence to reimagine and deliver ways to help make them a reality.

It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers.

Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

Contact: Pam Weagraff, Director, Med Tech Regulatory
Contact’s email: pamela.weagraff@iqvia.com

 

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Reed Smith

Reed Smith’s global Life Sciences Health Industry Group is multidisciplinary, involving the skills and experience of a core practice group of nearly 200 attorneys devoted entirely to the life sciences and health care fields. We have represented virtually every type of enterprise connected with the life sciences health industry—including many of the world’s largest pharmaceutical and medical device manufacturers, and all types of health care providers. Our work for device clients includes matters involving FDA regulatory counseling; reimbursement issues for new and established medical technology; contract pricing strategies; investigations; health care fraud and abuse compliance; and intellectual property issues.  We were honored to assist AdvaMed in matters involving the Association’s Code of Ethics with Health Care Professionals, and the CMS Open Payments (Sunshine) legislation and regulations.

Contact:  Elizabeth B. Carder-Thompson, Partner 

View our white papers

Analysis of CMS' Proposed Medicare "Comprehensive Care for Joint Replacement" Model

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

Cybersecurity for Medical Devices: A Risk Mitigation Checklist for In-House Counsel

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R&Q provides regulatory and quality solutions that accelerate the success of medical device companies and improve people’s lives. R&Q exists to promote economic growth through regional partnerships, to provide a rewarding place to work, and to improve communities.

Contact: Stephen Biernacki, Marketing Manager

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Sidley Austin LLP

Sidley Austin LLP is a premier law firm providing a broad range of services to meet the needs of large and small businesses across a multitude of industries, financial institutions, governments and individuals. Our Global Life Sciences practice counsels clients across three continents on the spectrum of issues manufacturers face throughout the life cycle of their products. Our team of more than 300 practitioners assists with matters involving all key areas of law, including: food, drug and medical device regulatory; compliance, enforcement and litigation; intellectual property; antitrust/competition; corporate and technology transactions; private equity; FCPA/anti-corruption; government strategies; privacy, data security and information law.

Contact: Rebecca K. Wood, Partner, 202.736.8663

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