Ceram adds Gel Permeation Chromatography to its Analytical Capabilities
Ceram, the materials development and testing company, has recently invested in GPC (Gel Permeation Chromatography (GPC), a technique which enables...
May 07 2013,
American Academy of Orthopaedic Surgeons Launches Shoulder and Elbow Registry
Design Control Hot Buttons to Expect During an FDA Inspection
FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention...
May 07 2013,
Six Steps to ISO 13485 Certification
ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a...
May 06 2013,
Interstate Plastics Expands its Range of Plastic Material, Machining and Fabrication Services
Interstate Plastics has expanded its range of plastic services as it seeks to position itself as North America’s largest plastic...
Apr 24 2013,
Millstone Medical Outsourcing Expands Medical Device Distribution Services
The impetus for development of the service was the complexity of licensing requirements, which differ from state to state....
Apr 24 2013,
Tour Norman Noble’s Medtech Contract Manufacturing Facilities Online
Norman Noble launched a new virtual tour of its manufacturing facilities on its web site, www.nnoble.com. From its dedicated prototype departments,...
Apr 18 2013,
Case Study: Moist Heat Sterilization of Reusable Device and Tray System
This case study, “Sterilization by Moist Heat Sterilization at 132C of Reusable Device and Tray System,” systematically investigates the role...
Apr 17 2013,
Three Reasons Ireland’s Orthopaedic Sector Attracts Foreign Investments
People, taxes and innovation are Ireland’s competitive advantage that attracts investment from overseas orthopaedic companies....
Apr 17 2013,
FDA Recognizes Computer Simulated Performance Data in Device Evaluation
FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation....
Apr 17 2013,
What if Your ISO Auditor is Wrong?
Auditors are human. The question is: What should you do when they're wrong?...
Apr 17 2013,
Just Because You’re Trained, Doesn’t Mean You’re Competent
Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination...
Apr 17 2013,
Industry Outlook Remains Positive Despite Excise Tax
Survey finds medical device professionals are more positive about the business environment, excise tax, regulatory environment and emerging markets major...
Apr 17 2013,
Strategic Orthopaedic 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen...
Apr 17 2013,
St. Vincent, Austen BioInnovation Institute Announce Strategic Partnership to Develop New Products
Austen BioInnovation (ABIA) and St. Vincent Charity Medical announced a Strategic Innovation Partnership, initially focusing on orthopaedics, to pair engineers...
Apr 16 2013,
gSource Announces Donation of Instruments to FOCOS Orthopedic Hospital in Ghana
gSource made a recent donation of surgical instruments to the Foundation of Orthopedics and Complex Spine (FOCOS), a 501c3 nonprofit organization. The...
Apr 11 2013,