How to Incorporate Software Validation in Your Device Design and Quality Processes
In our latest Ask the Expert article, we answer how software validation fits with your SOPs for design validation and...
May 25 2020,
Regulations
How Will FDA’s CDRH Reorganization Impact Me?
The goal of the CDRH reorganization was to drive operational efficiencies. Some organizations will feel the impacts of changes more...
May 12 2020,
EU MDR Postponement Clears Another Hurdle
The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ...
Apr 21 2020,
COVID-19: What CDRH Wants You to Know about Regulatory Submissions and Clinical Trials
FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the...
Mar 25 2020,
MDR Deadline Still On—for Now
The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others...
Mar 24 2020,
How to Approach Risk Management Under ISO and MDR Updates
Question: How do I handle medical device risk management and the change from ALARP to AFAP? Virginia Anastassova of StarFish...
Mar 05 2020,
Arthroscopy Pumps Targeted in New FDA Guidance
FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of...
Feb 10 2020,
ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management
The medical device risk management standard was updated to better align with changes in medical device regulations around the world....
Jan 20 2020,
CMS to Remove Total Hip Replacement, Certain Spine Procedures from Inpatient Only List
Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and...
Dec 02 2019,
3 FDA Actions to Reduce Ethylene Oxide Sterilization
FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight...
Dec 02 2019,
New Trademark Laws Stress Quality and Integrity of Registration
The United States Patent and Trademark Office has enacted policy changes to post-use audits and foreign applications. The new laws...
Nov 18 2019,
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant...
Nov 14 2019,
FDA Applies Special Controls to Instrumentation for Certain Osteochondral Implants
FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls)....
Nov 04 2019,
4 Key Elements of Design Controls
Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as...
Nov 01 2019,
FDA Announces Advisory Panel, Releases Report on Metal Implants
FDA says gaps exist in both knowledge and the available tools that are necessary to understand and assess biological responses...
Oct 22 2019,