Archive for January, 2012
Like most companies manufacturing medical products, Myriad has to operate under the guidance of certain standards. In October we underwent our annual ISO 13485 audit, conducted by BSI. Some of the areas reviewed were: corporate management, our quality system and manual, incoming inspection records, tool and equipment calibration, CAPA’s, and traceability records. The result of the one day audit was that we passed, and retained our ISO certificate for another year.
In November, at the request of one of our medical customers, we were audited by TUV to determine if Myriad was compliant to JPAL: MHLW Ministerial Ordinance No. 169, 2004. JPAL is the Japanese equivalent to America’s FDA. Being compliant would allow any of our customers to sell their Myriad manufactured product in Japan. Our customer was pleased to get a report that confirmed that Myriad is compliant to the JPAL standard, as well as to ISO 9001.
And then, to close out our year, in December, one of our customers conducted their own on site audit of our overall quality system. The auditor found no deficiencies in our procedures and documentation; and issued a statement that declared that Myriad met all of its quality requirements.
Blog Post by
QA & Engineering
Myriad Fiber Imaging
On Thursday night, November 17, Jim McDonald and Danna Mancini attended the November monthly meeting of the New England Section of the Optics Society of America. The meeting was held in the Photonics Center, at Boston University. The topic for the evening was – Smaller Is Better: Ever-Shrinking Optical Components Enable Novel and More Capable Medical Devices. The presenter was Randal Chinnock, Founder & CEO of Optimum Technologies, Inc.
Myriad Fiber Imaging was one of three corporate sponsors supporting Mr. Chinnock’s presentation. The company provided a 0.90mm diameter, flexible image scope, and a small LED light source, for demonstration purposes.
Some of the many products and technologies presented include: ground and polished lenses as small as 0.25mm in diameter, glass right angle prisms measuring only 0.18mm, miniature flexible endoscopes 0.50mm in diameter, plastic injection molded lenses, 0.65 diameter battery powered LEDs, and less than 2mm diameter ‘camera-on-chip’ image scopes.
Myriad’s staff is constantly evaluating emerging parts and processes for possible impact on the imaging and illumination marketplace. So, while all the products and technologies were presented as stand-a-lone components, Jim and Danna were specifically interested in how they could be combined with current Myriad offerings, to make new and unique products. Shortly, Myriad will acquire samples of some of the items introduced at the meeting. We will then test these components, assemble them into prototypes, and attempt to create new imaging and illumination systems.
If we are successful, you will be the first to hear about, here on our blog. Stay tuned.