Examining Methods to Determine Sample Sizes
Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using...
Dec 05 2017,
Iotron Industries Expanding Sterilization Capacity
Why a Well-Conceived Test Plan is Crucial to Efficient Product Development
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance...
Dec 05 2017,
Magnus René and Johan Brandt (CEO and CFO) Announce Plans to Leave Arcam
René will remain with the company until June 3, 2018 or until a new CEO is named; Brandt will remain...
Dec 04 2017,
Learn to Incorporate Sensors Into Your Next Design Idea
Microelectromechanical Systems, referred to as MEMS devices or sensors, are being used for tasks that were previously only conceived of...
Dec 04 2017,
Sanford Health Stem Cell Therapy Trial First in U.S. for Shoulder Injuries
The hospital system is attempting fat-based stem cell treatments on orthopaedic patients, using the cells to heal small/partial thickness rotator...
Dec 04 2017,
Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA...
Dec 04 2017,
Understanding the Critical Differences Between Supplier Audit and Evaluations
Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them...
Dec 04 2017,
Arcam to Evaluate Strategic Alternatives for DTI
Arcam purchased DiSanto Technology in 2014 for US $15.8MM in cash and stock....
Dec 01 2017,
Concept Laser, GE Break Ground on 3D Printing Campus
The Lichtenfels, Germany facility will house around 500 employees and will open in early 2019....
Dec 01 2017,
Precision Medical Technologies to Expand Indiana Operations
The company is investing nearly $5 million in a new facility that will create up to 60 jobs by 2022....
Nov 30 2017,
UDI Direct Marking Guidance Finalized by FDA
FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account...
Nov 28 2017,
DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle
The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total...
Nov 27 2017,
Tegra Medical Names General Manager of Mississippi Plant Operations
Randy Sible has over 17 years of management experience in medical devices, aerospace/defense and equipment manufacturing....
Nov 27 2017,
Invibio Makes Series of Investments to Drive Clinical Outcome Improvement
The investments include faster time-to-market for devices through streamlined device-development strategies that consider the total costs of care....
Nov 17 2017,
Elos Medtech Increasing Global Orthopaedic Resources
The company has named Elos Medtech Onyx Managing Director Jodie Gilmore as its new Orthopaedic Business Director. ...
Nov 16 2017,