Boyd Industries has registered certification to ISO 13485:2016, the international standard for excellence in medical device manufacturing and safety. This certification demonstrates the company’s focus on providing safe, high-quality medical equipment in an ever-changing marketplace.
(Clearwater, FL) February 20, 2017—Boyd Industries, a dental equipment manufacturer, is proud to announce the company’s certification to ISO 13485:2016, the internationally recognized standard guiding medical device producers in implementing quality management systems to achieve industry distinction.(1)
ISO 13485:2016 certification is important not just to companies in the medical device industry, but to dentists around the world. The global dental equipment market is expected to grow to $7,138.9 million by 2019.(3) With growing investment and interest in the globally connected medical device marketplace, it’s more important now than ever for companies to be held to the highest possible standard obtainable through certification and registration processes. This helps to ensure delivery of safe, reliable medical devices to patients around the world by holding manufacturers accountable for producing exceptional products.
Adrian LaTrace, CEO of Boyd Industries, said, “Our company has made a commitment to both customers and regulators to manufacture and sell dental equipment of unparalleled quality. With the achievement of ISO 13485 certification, we’re celebrating our pledge to supply dental customers worldwide with dental office equipment that is both safe and made to last.”
This certification is the most recent version of the international standard, designed in response to technology innovations and changes in expectations and regulatory requirements. (1) Each ISO standard undergoes revision every five years, unless markets determine that a premature revision is necessary to keep a particular standard relevant. ISO 13485 was created to direct businesses in the design, production, installation and servicing of medical devices and related services. (2)
Boyd Industries achieved its certification, and although it’s not a specific requirement of the standard itself, the company pursued registration to demonstrate its continued commitment to excellence and safety in the medical device industry. Certification was achieved by way of a third-party organization, BSI, and was registered with ISO after completion.
LaTrace said, “Our competitive analysis of the medical device industry indicated that many of our direct competitors in the marketplace are not ISO registered. Our company chose to publicly demonstrate our pledge to producing medical devices that comply with internationally recognized standards of excellence; in turn, we’ve raised our own standards in the design, manufacture and sale of our products.”
One of the most cost-effective ways in which dentists can remain current is by investing in quality dental equipment from the start of their practice, rather than upgrading or replacing equipment frequently. Purchasing state-of-the-art equipment ultimately drives dental office costs down, since there is no need to replace or repair old or malfunctioning equipment on a regular basis.
It’s important for dentists, when choosing an equipment vendor, to realize that there is a difference in the standards of different companies. A company’s dedication to quality is easily measurable by the use of international standards such as ISO 13485. Through the certification process, Boyd Industries has set itself apart from the competition and is recognized as a trusted and respected source of high-quality dental equipment for modern practices.
About Boyd Industries:
Boyd Industries is a market leader in the design and manufacture of specialty dental and medical operatory equipment. Its high-quality and reliable equipment has been the choice of orthodontists, pediatric dentist, oral surgeons and other healthcare professionals for 60 years. Boyd’s products include a full line of dental exam, treatment and surgical chairs, dental delivery systems, LED exam and surgical lighting, custom sterilization and storage cabinetry, doctor or assistant seating, and video game consoles.
Boyd equipment is specifically designed to provide maximum practice productivity while incorporating ergonomic characteristics for doctors, their staff, and their patients. As an original equipment manufacturer, Boyd uses a vertically integrated manufacturing approach to assure it meets high quality standards. This approach allows Boyd to control each step of component fabrication and product assembly. To learn more about Boyd products, please visit http://www.boydindustries.com/home.
About Adrian LaTrace:
Adrian E. LaTrace comes to Boyd Industries with more than 25 years of leadership in companies ranging from start-ups to large public corporations in the healthcare, renewable energy and aerospace industries. His experience in developing high-performance organizations is helping Boyd provide leadership for the dental equipment needs of the future.
Sources: 1. ISO 13485 – Medical devices. ISO.org. http://www.iso.org/iso/home/standards/management-standards/iso13485.htm
2. ISO 13485:2016, Medical devices – Quality management systems—Requirements for regulatory purposes. ISO.org. http://www.iso.org/iso/catalogue_detail?csnumber=59752
3. How to keep up with the ever-increasing changes in dental technology. Dentistry IQ. http://www.dentistryiq.com/articles/2016/06/how-to-keep-up-with-the-ever-increasing-changes-in-dental-technology.html
Karla Jo Helms
Phone: 888-202-4614 ext. 802