ALLIED and Associate mEMBERS

You can rely on Centurion Sterilization Services for your sterilization needs. We specialize in turnkey sterilization validation programs and customized EO cycles, featuring 3 and 7 day release options. Centurion is capable of handling all product volumes—from single cases to truck loads. Our on-site, full service laboratories provide faster turn-around times. We have three facilities strategically located to handle logistics for every region of the country. You can count on full regulatory support, including protocol preparation, full documentation and final report package. Centurion is ISO13485 certified, EN550 compliant, and FDA registered.

www.centurionsterile.com

Disposable Instrument Company manufactures custom metal disposable medical components and devices, as well as a line of standard wound drainage trocars for the medical manufacturer. As components, our devices contribute high value through overall quality including unsurpassed sharpness, smoothness and cleanliness, freedom from manufacturing defects and corrosion, outstanding appearance and reasonable prices.
All of our products are manufactured to our customer’s specifications and require additional components, packaging and sterilization before they are ready for distribution or sale to doctors or hospitals.

In addition to wound drainage trocars, the company manufactures aluminum and stainless-steel products such as laparoscopic trocars, Steinmann pins, K-wires, obturators, tunnelers, introducers, passers, guide pins, bone drills, special suture needles, and cannula/trocar assemblies. The company also offers prototyping services for product development.

www.disposableinstrument.com

Minnetronix is a medical device outsourcing company, specializing in the design, manufacturing and support of electronics-based medical devices. Minnetronix’ experienced engineers and manufacturing teams provide expertise on a wide range of Class II and Class III medical equipment, such as cardiovascular systems, point-of-care diagnostic instruments, therapeutic devices, implantable devices, and monitoring equipment. Minnetronix has completed more than 100 development and manufacturing projects for more than 75 different medical device companies that range in size from small start-ups to large established firms. Minnetronix is ISO 13485:2003-certified and is an FDA-registered contract manufacturer.

www.minnetronix.com

Premium Members

Argenta Reimbursement Advisors provides strategically integrated reimbursement solutions to life science companies. Argenta’s focus is to deliver actionable strategic reimbursement counsel in order to work in concert with achieving the client’s business objectives. The Argenta team has the unique ability to leverage its expertise along the full continuum from strategy formation and coding and payment systems analysis to payer negotiations and customer reimbursement support. This means that Argenta can be a single-source solution for addressing the unique and often complex reimbursement needs of companies in the medical device industry.
www.argentaadvisors.com

If you are looking for world class service, look no further than the member insurers of the Chubb Group of Insurance Companies (“Chubb”). Chubb is a leader in the property and casualty insurance industry as a result of consistently striving to build lasting relationships. For more than 20 years, Chubb has been providing cost-effective risk management and insurance products and services tailored to the needs of medical device companies. Chubb's insurance professionals specialize in the medical device market; they understand the issues and develop responsive solutions.
www.chubb.com

Operating in more than 100 countries, IMS Health is the world's leading provider of market intelligence to the healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients' day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and over-the-counter offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide.

IMS applies evidence-based intelligence - combining the best global healthcare information with powerful analytics and healthcare consulting expertise – to help our clients shape business strategies, make superior decisions, and achieve a competitive edge.
www.imshealth.com

Mintz Levin is an AmLaw 100 law firm with offices in the US and the UK. The firm has exceptional depth in a broad range of practice areas, but our clients recognize that what sets us apart from other law firms is our industry focus. By truly understanding business drivers and industry trends, we are able to provide our clients with more than just legal advice; we provide legal solutions to our clients' business issues. Since 1933, our lawyers have represented entrepreneurs, emerging growth companies, Fortune 500 companies, government agencies, not-for-profit organizations and leaders in primary industries that include Healthcare; Life Sciences/Biotechnology; Technology & Communications; Energy & Clean Technology; Financial Services & Insurance; Real Estate, Hospitality & Construction; and Retail & Consumer Products. Our practical knowledge combined with our industry expertise enables us to provide our clients with enterprise legal advice that gives their business a competitive advantage in the marketplace.
www.mintz.com

Pacific Bridge Medical (PBM) is a leading medical consulting firm dedicated to assisting medical companies in Asia. Our consultants have helped over 200 medical companies with business development and regulatory affairs in Asia since our founding in 1988. Our services include registering medical products, finding distributors, sourcing/manufacturing, setting up joint ventures, conducting market research, and more. We can help you in China, India, Japan, Korea, Taiwan, and other Asian countries. We also host monthly Asia medical webcasts and publish updated medical reports available for sale. We publish a FREE monthly Asian Medical eNewsletter. Please see our website at www.pacificbridgemedical.com to subscribe.

R-Squared —for “reimbursement and regulatory”—provides compliance software and services for healthcare and life sciences organizations. Our solutions combine expert knowledge from leading health lawyers and compliance officers with the latest in technology, and range from off-the-shelf software products to full service engagements that encompass compliance program assessments, internal controls enhancements, risk mitigation controls, and full-featured custom software solutions and training. As leading proponents of “Evidence-Based Compliance,” and to satisfy government enforcements efforts, R-Squared created RADS—“regulated arrangements database solution”—which consists of two independent software modules: Arrangements Keeper, which manages and evidences compliance around financial relationships with referral sources (e.g., consulting agreements, grants, case studies); and SpendTracker, which reduces the administrative burden and facilitates compliance with state marketing/gift reporting and disclosure laws. Currently, RADS is used to manage over 5,000 regulated arrangements for leading companies throughout the United States.

www.r2ss.com

Quintiles Consulting provides global regulatory, product development, clinical, compliance and validation consulting services to the medical device industry.

We are results focused and have established an impressive record of tangible benefits for our customers – we do what we say. Out cadre of experts include former FDA investigators and seasoned industry experts with years of “know-how” in designing and implementing compliant systems. Our former FDA reviewers can guide you through the device review process efficiently and effectively.

Whether your needs are small – an hour of expert advice; or large – fulfilling the requirements of an FDA consent decree, Quintiles Consulting has the depth of expertise and the right resources to fulfill them.
www.quintiles.com/quintilesconsulting

Tarius® offers customized regulatory and quality intelligence web portals for pharmaceutical and medical device companies. Given the complexity of the regulations and the high cost of non-compliance, more and more companies are turning to Tarius for a single view of up-to-date regulatory directives, FAQs, expert opinions and reference documents from over 60 countries. Tarius is valued for its “google-like” simplicity that makes it more efficient, reliable and faster to access the regulatory and quality information needed to reduce regulatory risk. Go to www.tarius.com for more details and your free trial offer.

Three Arch Partners was formed in 1993 to provide young companies with access to relevant clinical and business resources, as well as capital.  Three Arch Partners has helped create, build, and fund more than 100 healthcare companies.  The investment focus in on opportunities in medical devices and healthcare services, as well as biotechnology and information technology.  The partnership manages over $1 billion in capital. 
www.threearchpartners.com

Underwriters Laboratories Inc. 
Underwriters Laboratories, Inc. (UL) is a regulatory service provider helping medical device companies through the regulatory process. UL is the only provider based in North America offering a complete regulatory solution for today's global medical device market including registration to ISO 13485:2003, QMS Registration for Canada, Technical File approvals for Europe and Japan, InMetro qualification for Brazil, gap assessments for Risk Management to ISO 14971, and FDA 510(k) Third Party Reviews. UL continues to support the medical device industry through ongoing expansion of regulatory services and support of organizations like MDMA who support the medical device industry.
www.ul.com

Vasco Advisers is a small European consulting company working with business and strategy development - mainly in the medical sector.

Our clients are medtech / biotech and pharma companies, investment and VC firms, public and private healthcare service providers, healthcare policy makers and other players active in the healthcare sector.

Our consultants have solid understanding of:

• The entire medical value chain - from product development to health care services and the patient process
• Markets that are regulated or being deregulated
• International business and strategy development in the medical sector

www.vascoadvisers.com