Medtech stories we missed this week: May 25, 2018

From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press releasethat it has received FDA 510(k) clearance for

3 ways to streamline global medical device registrations

Global medical device registrations can be time-consuming and costly for organizations. Here are some ways to make the process better. Alex Butler, MasterControl Obtaining clearance or approval for a medical device in the U.S. is cause for celebration. Obtaining clearance or approval for a medical device in multiple foreign countries is cause for jubilation. On

Will FDA turn to neuroscience-based human factors research?

There is a new wind blowing in medical technology — one that many believe is overdue: an overhaul of human factors. At the recent Patient Safety Initiative, Charles Murphy, Chief Patient Safety Officer at the Inova Heart and Vascular Institute, called out human factors as one of the key factors he believed needed to be

Webinar: How to balance regulations and performance with your medical device design

Wednesday, June 20, 2018 2 p.m. Eastern time / 11 a.m. Pacific time     Creating a medical device that meets both regulatory compliance and performance requirements takes careful planning. You also need to understand the most efficient path to market commercialization in order to stay within budget and on schedule. This is no simple

Brazil Anvisa changes market pathway for low-risk medical devices

By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not

Medtech stories we missed this week: May 11, 2018

From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press releasethat it has submitted an application to the Medical Devices Bureau of

FDA clarifies multiple-function medical device oversight policy

Stewart Eisenhart, Emergo Group New guidance from the U.S. Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not

Speakers you need to see at DeviceTalks Minnesota

A Google executive whose own heart problems spurred her to seek medtech innovation, a leader at Abbott who wants to drive healthcare value, the head of an upstart company seeking to transform diabetes care — those are but some of the speakers you will encounter at DeviceTalks Minnesota this June. Read on to find out

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Medical device recalls significantly increase during Q1

The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7%

7 QMS tools to demonstrate compliance with 21 CFR Part 820 for medical devices

Rachel Beavins Tracy, EtQ 21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance. So, how can manufacturers use the QMS to demonstrate compliance with

Greenlight Guru’s newest software version enhances QMS, complex design tracking

Greenlight Guru — which offers cloud-based quality management software specifically for medical device companies — recently announced Multi-Level Design Control, the latest version of its purpose-built medical device design traceability software. The new platform improves on Indianapolis-based Greenlight Guru’s previous offering that moved design controls off the paper and into the cloud, said Greenlight Guru co-founder

Is FDA’s easing of medical device malfunctioning reporting a good thing?

The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA. “I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing. FDA’s solution has partly been to propose an easing of the reporting requirements.

DDL adds medical device testing to new Irvine lab

DDL said today that it now offers medical device testing at its new DDL West laboratory in Irvine, Calif. The DDL West lab recently moved from Fountain Valley, Calif., to a new facility in Irvine that has double the lab space of the old location. Previously, testing of catheters, luers, needles, syringes, guidewires and IV infusion only took place at DDL’s headquarters

Medtech stories we missed this week: April 27, 2018

From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed

Eudamed completes actors module testing

By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post