MCRA Presents on Medical Device Regulation to Chinese FDA
The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process....
May 03 2018,
4 Human Factors Practices that Lead to Successful FDA Submission
Eight Steps to Project Triage
Choosing which high-priority projects to work on first can be a challenging task; forming a strategy for triage is a...
May 01 2018,
LaVezzi Precision Acquired by MW Industries
The contract manufacturer will join the MW Medical Solutions brand....
Apr 27 2018,
NN Life Sciences Facility Receives MDSAP Certification
This will allow NN Life Sciences to sell more of its products into new markets using its existing regulatory program....
Apr 24 2018,
Medbio Receives ISO 13485:2016 Certification
This certification is the culmination of the company’s year-long effort to upgrade its Quality Management System....
Apr 24 2018,
ConnectSx Launches Free Inventory App for Sales Reps
The iOS-native mobile app brings transparency to the surgical supply chain by helping users schedule cases, manage inventory, track UDI...
Apr 24 2018,
Successful Medical Device Design Transfers Hinge on Advance Planning
Elements of a well-constructed plan include an understanding of regulatory requirements, a comprehensive review of all documentation and a thorough...
Apr 23 2018,
Start Simple: Advice to Effectively Use Statistical Methods in Process Validation
Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable...
Apr 23 2018,
Nelson Laboratories Expands Operations, Testing Capabilities
Service capacity is doubling at the company’s Itasca, Illinois lab....
Apr 20 2018,
Precision Medical Technologies Opens New Facility
The contract manufacturer's second location will produce surgical instruments....
Apr 20 2018,
Cadence to be Acquired by Investment Firm Kohlberg & Company
Cadence’s leadership and management team will remain in place post-transaction....
Apr 18 2018,
3Diligent Expands Digital Manufacturing Services
The company, specialists in additive manufacturing, is adding comprehensive machining and casting services....
Apr 18 2018,
Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI
Patrick Sweeney, M.D. is Founder of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Illinois that addresses...
Apr 18 2018,
Evonik Launches New Composites, Intensifies Research on Regenerative Medicine
The company’s RESOMER Composites are designed to enhance the performance of bone fixation devices; a new Tissue Engineering Project House...
Apr 17 2018,
Medin Technologies Appoints Bill Donaldson as CEO
His experience includes guidance of companies through critical transformation periods....
Apr 17 2018,