Boyd Industries Achieves ISO 13485 Certification

Boyd Industries, a dental equipment manufacturer, has achieved ISO 13485:2016 certification, 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 $7.13 billion 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 E. 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.
 
“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,” LaTrace said.
 
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.
 
Boyd Industries designs and manufactures specialty dental and medical operatory equipment. Its 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 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.

References:
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