Showing items tagged as Medical Device

  • 5 Ways 2020 Changed the Regulated Medical Industry

    January 4, 2021 By Regina Fullin, VP of RA/QA Consulting

    With 2020 behind us, let’s take stock of what happened during the year and how the face of regulated medical industry has changed. Heading into 2021, be ready for remote options, deferred enforcement of regulations and more.

    Full story
  • A Risk-Based Approach to Validation

    December 30, 2020 By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

    Full story
  • Five Best Practices for Ensuring Supplier Quality

    December 21, 2020 By David Jensen, Staff Writer, MasterControl

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

    Full story
  • Brexit and the Impact on the IVD and MD Industries

    December 8, 2020 By Dr. Dirk Stynen, Owner, President and Principal Consultant, Qarad

    On January 1, 2021 the United Kington will leave the European Union. The implications of this move have a significant impact on manufacturers.

    Full story
  • EU’s MDR Calls for Summary of Safety and Clinical Performance

    November 3, 2020 by Dave Jensen, Staff Writer

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

    Full story
  • Is Your Design History File Prepared for an FDA Inspection?

    September 25, 2020 By David Butcher, Staff Writer

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

    Full story
  • Overview of ISO 13485 – Medical Device Quality Management System Requirements

    August 26, 2020 by James Jardine, Staff Writer

    Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.

    Full story
  • Software as a Medical Device – Upcoming Changes to the Australian Regulations

    July 17, 2020 by Belinda Dowsett, Quality Assurance Manager and Consultant

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

    Full story
  • What Verification and Validation Activities are Required for a First in Human Study?

    June 23, 2020 By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

    Full story
  • EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    May 26, 2020 by Gert W. Bos, PhD, Fraps, Executive Director and Partner, the QServe Group

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

    Full story
  • A Data-Centric Approach to Propel the Future of Device Innovation

    May 12, 2020 by Mike Rigert, Staff Writer, MasterControl

    Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.

    Full story
  • What 2019 Data Reveals About FDA’s 510(k) Program

    April 30, 2020 by Luis Jimenez, Vice President of Business Development, Brandwood CKC

    The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.

    Full story
  • 3 Trends That Can Improve Manufacturers’ Speed to Market

    April 23, 2020 by David Butcher, Staff Writer, MasterControl

    Technologies are evolving and maturing, and regulatory bodies are reacting to remove unnecessary roadblocks for device companies while protecting consumer safety. Manufacturing organizations that embrace these opportunities will be better positioned to achieve significant efficiencies in product discovery and development, regulatory compliance and, ultimately, speed to market.

    Full story
  • 3 Medical Device Trends for 2020

    March 12, 2020 by Mike Rigert, Staff Writer, MasterControl

    Advanced technology, market growth and regulatory disruption are creating an opportunity-rich but also demanding medical device space in 2020. An overview of some of the most impactful medtech trends of 2020 gives companies insights on how the industry is evolving and offers ways to flourish in a more data-driven ecosystem.

    Full story
  • Christmas Comes Early to Medtech: U.S. Repeals Device Excise Tax

    January 16, 2020 by Mike Rigert, Staff Writer, MasterControl

    With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.

    Full story
  • To Pre-Sub or Not to Pre-Sub? Weighing the Value of the FDA’s Pre-Submission Program

    January 7, 2020 by J. Lawrence Stevens, RAC and principal consultant, One Way Consultants

    The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.

    Full story
  • Innovation and Compliance Harmonize Perfectly at Cochlear

    December 10, 2019 by James Jardine, Staff Writer, MasterControl

    Cochlear’s cochlear implants are more than just groundbreaking medical devices — they’re a life-redefining means through which people with hearing loss to connect with the world. Learn how the company is bringing innovative products to more people in need by accelerating quality and compliance processes with robust digital solutions.

    Full story
  • The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

    November 21, 2019 by Mike Rigert, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.

    Full story
  • It’s A Charlie Brown Audit

    November 19, 2019 by David Jensen, Staff Writer, MasterControl

    Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.

    Full story
  • 3 Clinical Trends Shaping the Medical Device Space in 2019

    September 19, 2019 by Mike Rigert, Staff Writer, MasterControl

    The medical device industry is changing at a pace that most in the industry are struggling to keep up with. And nowhere is that more evident than in medtech’s clinical research and trials space. Glean some of the hottest new clinical trends as we move into Q3 and Q4 of 2019.

    Full story