UDI Update: Prepping for the Final Ruling
OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines....
Jul 10 2013,
Competitive Landscape
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Manufacturers often use a 200-year-old, outdated process to arrive at the cost of producing product.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,
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,
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,
The Basics: A Look at the French Medical Device Market
France’s medical device industry faces a high level of competition. Biomatlante shares its experience operating in its home country....
May 08 2013,
Conquering the German Market in Six Months
The German healthcare and medical device industries are the largest in Europe. To be a successful player in the market,...
May 07 2013,
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,
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,