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

    16 January, 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
  • 3 New Year’s Resolutions for Your Company

    14 January, 2020 by Sarah Beale, Staff Writer, MasterControl

    The new year is the typical time when we set resolutions to improve ourselves. Since companies are in need of improvement too, make a resolution to digitize your business. If you’re not sure how to start, we’ve got some ideas.

    Full story
  • 7 Critical FDA Concepts for Pharmaceuticals Quality Systems

    14 January, 2020 MasterControl

    From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

    Full story
  • 7 Steps to Ensure CAPA Success

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

    Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action preventative action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.

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

    7 January, 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
  • 3 Keys to Implement an Integrated Management System With ISO 9001

    31 December, 2019 by Christine Park, Founder and Owner, Christine Park and Associates

    Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.

    Full story
  • The Standards Harmonization Process and 5 Tips to Manage It With EU MDR

    24 December, 2019 by Dr. Arthur Brandwood, Director and Principal Consultant, Brandwood CKC

    There’s been considerable disquiet over the lack of available harmonized standards to support the European Union’s Medical Device Regulation (MDR). Learn about European harmonization standards processes and how medical device manufacturers can best manage the current state of regulatory uncertainty.

    Full story
  • Purpose-Built Manufacturing Systems: Once a Virtue, Now a Vice

    19 December, 2019 by Beth Pedersen, Staff Writer, MasterControl

    As technology and the marketplace undergo drastic change, it seems the ROI of enterprise manufacturing software systems has reached a tipping point. But with the help of new additive technologies and small automation efforts, core systems will continue to play a significant – albeit evolving – role in modern manufacturing.

    Full story
  • Santa’s Little Auditor

    17 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.

    Full story
  • Surge of Data Integrity Violations Irritating the FDA

    12 December, 2019 by David Jensen, Staff Writer, MasterControl

    Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.

    Full story
  • The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    11 December, 2019 by Mike Rigert, Staff Writer, MasterControl

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

    Full story
  • Innovation and Compliance Harmonize Perfectly at Cochlear

    10 December, 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
  • Digital Supply Networks and Smart Factories: The Future of Manufacturing

    5 December, 2019 by Mike Rigert, Staff Writer, MasterControl

    The further we go into the 21st century the more it becomes apparent that the future of manufacturing will be digital. Find out how digital supply networks and smart factories will form the backbone of the digital transformation and what role quality and an automated quality management system (QMS) will play as manufacturing enters the Fourth Industrial Revolution.

    Full story
  • 5 Ways to Prepare for the Future of Quality Now

    4 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

    Full story
  • Survive Holiday Cooking With Recipe Management

    3 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    If you’re stressed about holiday meal preparation, get some help from digitizing your system. Trade out the flour-crusted recipe notecards for a recipe management system that brings precision to your cooking. This year, it’s the only way to face your in-laws with confidence.

    Full story
  • Why MDSAP Opens a World of Opportunity for Med Devices

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

    Global regulatory agencies are rallying to help drive the momentum for medical device innovation. The International Medical Device Regulators Forum (IMDRF) recently implemented a regulatory consortium called the Medical Device Single Audit Program (MDSAP). The program is designed to grant regulatory approval of medical devices in several global regions through a single audit. In this article, Luis Jimenez, vice president of business development at Brandwood CKC, discusses why this program is highly beneficial for medical device manufacturers.

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

    21 November, 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

    19 November, 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
  • World Quality Day 2019: Celebrating the Past, Present and Future of Quality

    14 November, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Have you ever thought about what quality means to you? It may mean something different to everyone, but its power to change lives for the better unites people around the world. On World Quality Day, we celebrate this uniquely human concept and the impactful work of quality professionals everywhere by taking a moment to reflect on the past, present and future of quality.

    Full story
  • An Assessment of the ‘Elevens’: EU’s Annex 11 and FDA 21 CFR Part 11

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

    The European Union’s Annex 11 and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 good manufacturing practice (GMP) guidances cover much of the same regulatory ground but also have differences. Find out how both regulatory documents affect life sciences manufacturers.

    Full story