Cadence Facility Receives 13485:2012 and ISO 9001:2008 Certification
Cadence, a provider of medical device outsourcing solutions, received ISO 13485:2012 and ISO 9001:2008 certification through BSI for its Pittsburgh,...
Jun 14 2013,
Able Medical Devices Achieves ISO 13485:2016 Certification
BSI Announces Supply Chain Verification Product
BSI America Professional Services announced market introduction of BSI Supply Chain Verification Service (VerifEye). Supply Chain Verification encompasses threat and...
Jun 13 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances: Apogee OrthoSolutions, Biomedical Enterprises, Cleveland Clinic/Custom Orthopaedic Solutions, Institute of Musculoskeletal...
Jun 07 2013,
Material Cost vs. Price Plays Important Role in Sensitive Market
Manufacturers often use a 200-year-old, outdated process to arrive at the cost of producing product. Failure to incorporate these 21st...
Jun 07 2013,
The Race to the Patent Office Is On
New regulations have converted U.S. patent law from a “first-to-invent” to a “first-inventor-to-file” system. These best practices will ensure you...
Jun 06 2013,
Bone Substitutes: Swapping Autograft for Bioactive Glass
Studies show bioactive glass is a viable treatment for complete bone repair. BONEZONE spoke with BonAlive about the science behind...
Jun 06 2013,
Seven Ways to Investigate Complaints When Devices Aren’t Returned
One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the...
Jun 06 2013,
Greatbatch Organizes for Accelerated Growth
Greatbatch announced a realignment of its operating structure to support a continued focus on profitable growth. Greatbatch Medical and Electrochem...
Jun 06 2013,
ECA Medical Instruments Expands to New Corporate Headquarters and Opens Design Center of Excellence
ECA Medical Instruments, a designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical...
May 30 2013,
Cadence Announces Major Expansion in Cranston, RI
Cadence, a manufacturer of precision products for the medical device and life science markets, broke ground on a 34,000 square...
May 30 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen...
May 09 2013,
Imaging in Medical Device Manufacturing
Manufacturers are facing significant pressure for more efficient, cost effective and higher quality production of their products. Imaging hardware and...
May 09 2013,
Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies
By working effectively through the timelines and deliverables from reimbursement, the regulatory pathway, data requirements and clearance, companies can bring...
May 08 2013,
Accutek Weighs In on the State of Testing
John McCloy built a nimble testing laboratory in order to handle economic and regulatory changes....
May 08 2013,
Spotlight on Europe
Companies seeking to expand within the European Union need to consider more than just regulatory factors. This month’s Global Spotlight...
May 08 2013,