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NSF International

Health Care

NSF International Expands Medical Device and Pharmaceutical Services

Acquisition of Pink Associates enables NSF to offer full range of services to the medical-device industry

Published: Monday, January 16, 2012 - 13:08

(NSF: Ann Arbor, MI) -- NSF-DBA, an NSF International Health Sciences company providing training, consulting, and auditing for the pharmaceutical and biopharmaceutical industries, has acquired UK-based medical-device training and consulting company, Pink Associates, with the company’s managing director, James Pink, joining NSF-DBA as a partner.

NSF-DBA (formerly David Begg Associates) helps an organization by improving its regulatory compliance, streamlining quality systems, and maximizing the contribution of its people through class-leading training, including a comprehensive range of training and post-graduate courses offered in the United States, Europe, and South Africa.

Pink Associates is the recognized expert for consulting and training in the medical device industry. The company consults within the medical-device product life cycle and includes planning clinical trials, developing product and process validation strategies, conducting training and academic research, and performing technical and quality management system audits to ensure manufacturers meet international medical device regulations.

The first offering to come as a result of the NSF-DBA acquisition is the new NSF-DBA Medical Device Diploma program, which provides medical device professionals with the knowledge, tools, and techniques needed to manage the many aspects of worldwide medical-device quality management and regulatory affairs. This program complements the wide range of existing courses offered through NSF-DBA.

The acquisition of Pink Associates positions NSF-DBA, and its parent NSF International, as the preferred global training, auditing, and consulting partner for medical device, pharmaceutical, and dietary supplement companies, and enables NSF to offer a full range of services to the medical device industry.

NSF-DBA is part of NSF International’s Health Sciences Division that also includes NSF’s dietary supplement certification programs and NSF Pharmalytica, which offers good laboratory practices (GLP) and good manufacturing practices (GMP) analytical testing (extractables and leachables), consulting, and research and development services to the pharmaceutical industry.

Now, through this acquisition, NSF can offer these services to the expanding medical device market. Additionally, NSF International Strategic Registrations Ltd. provides registration and training for compliance to ISO 13485—“Medical devices—Quality management systems—Requirements” from the International Organization for Standardization (ISO). This is important because according to IBISWorld, an independent publisher of U.S. industry research, the medical device industry has a projected annual growth rate of 16.3 percent.

Companies working with NSF-DBA and other NSF International units can now benefit from a team of experienced medical-device product development, validation, regulatory affairs, education, and quality assurance experts across Europe, the United States, and Asia. This includes an end-to-end range of services for the constantly growing medical device industry.

“Our clients continue to face complex technologies and regulatory frameworks with an increased focus on scientific validation and clinical evidence, and therefore must rely on professional services to help guide and educate them,” says James Pink, founder of Pink Associates and who now joins NSF-DBA as the partner overseeing the medical device sector. “Integrating our services with NSF-DBA will broaden our capabilities and position us as the experts able to help establish our clients’ development and regulatory plans as well as address their product and process validation needs, ultimately leading to the assurance to enter their global markets.”

“This acquisition will make NSF-DBA for medical device companies what we already are for so many pharmaceutical and nutraceutical companies: the preferred partner for their consulting, auditing, and training needs,” says NSF-DBA managing partner Bob Pietrowski, Ph.D. “We are delighted to have acquired Pink Associates and James Pink, as they have the knowledge, expertise, drive, and vision to grow our offerings to medical device manufacturers worldwide.”

For more information about NSF-DBA’s new medical device offerings, visit www.nsf-dba.com or contact James Pink at jp@nsf-dba.com or 44 (0) 114–2541270.

For more information about NSF International’s broad range of health sciences services contact Tom Morse at hs@nsf.org or (734) 214–6242, or visit NSF’s Health Sciences webpage.

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NSF International

Manufacturers, regulators, and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF’s mission is to protect and improve global human health. As an independent, accredited organization, its standards group facilitates the development of standards, and its service groups test and certify products and systems. NSF also provide auditing and risk management solutions for public health and the environment.