April 23, 2021
By David Butcher, Staff Writer, MasterControl
Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.
April 20, 2021
By Jean Boudaud, Device Consulting Manager and Senior Consultant, Brandwood CKC, and Brandwood CKC
As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.
March 11, 2021
By José Mora, Owner, Atzari Enterprises, L.L.C.
Controlled documents tend to be weighed down with unnecessary information. When lean principles are applied to documentation practices, it becomes evident that most documents can be trimmed down to a comprehensive and useful level while maintaining compliance.
February 15, 2021
By Christine Park, Founder and Consultant, Christine Park & Associates
The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.
February 4, 2021
By David Jensen, Staff Writer, MasterControl
An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.
January 4, 2021
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
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.
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.
August 13, 2020
By Mike Rigert, Staff Writer, MasterControl
Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.
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.
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.
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.
December 10, 2019
By James Jardine, GxP Lifeline Editor, 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.
August 21, 2019
By Jenny Lin, Consultant, Brandwood CKC
Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.
The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.
March 28, 2019
By Mike Rigert, Staff Writer, MasterControl
Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.
February 26, 2019
By Grant Bennett, CEO, Brandwood Biomedical
Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.
October 25, 2018
By David Jensen, Staff Writer, MasterControl
There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.
October 9, 2018
By Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)
Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.
September 4, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.
