Regulatory Articles
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Will Your Labeling Strategy Assure Compliance With EU MDR?
4/22/2019
The new regulation, which entered into force in May 2017, imposes major new rules on companies involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. Will your labeling strategy assure compliance With EU MDR?
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The Recurring Insanity Of Med Device Labeling Recalls
4/22/2019
Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls. In 2018, nine percent of all medical device recall events – and the return of over a million units – were due to labeling issues.
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Providing A Labeling Backbone For Medical Device Manufacturer: Boston Scientific
4/22/2019
Boston Scientific, one of the world’s largest medical device manufacturers, was looking to standardize on a single labeling system. The project initially arose when a worldwide branding exercise highlighted the huge variances in label formats and styles on secondary packaging; standardizing on a single labeling system would offer consistency, increase efficiency and compliance.
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EU MDR Labeling Compliance: Learning The Lessons From UDI
4/22/2019
As organizations struggle to meet the challenges of EU MDR, there are many lessons to be learned from the UDI experience. This paper presents those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations.
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Ensuring FDA Compliance: The Essential Guide To FDA 21 CFR Part 11
4/22/2019
FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical product.
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Developing The Right Strategy To Assure Compliant Labeling Inspection
4/22/2019
Understandable concerns about the cost and consistency of new technologies have convinced many companies to maintain traditional methods of labeling inspection. However, much of the industry appears oblivious to FDA regulations around quality requirements for label inspection.
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10 Steps To EU MDR Labeling Implementation
4/22/2019
The European medical device industry is in the grip of the biggest change the market has seen in decades and the European Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, a manufacturer or supplier will need to adhere to the new EU MDR. This white paper presents 10 steps required to make the implementation of EU MDR labeling simpler.
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Beyond Making The Part: Understanding Enhanced Qualification
3/1/2019
Working with a micro molder to develop an Enhanced Qualification (EQ) process for critical parts can save money and time by ensuring a smooth transition into full-volume production.
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Toxicological Risk Assessment Of Medical Devices: An Overview
4/19/2018
The FDA requires toxicological risk assessments performed for most medical device submissions founded on the notion that if all of the constituents of a medical device are known, then the safety of the device can be assessed based on the toxicology of those constituents.
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Reducing The Life Cycle Cost Of Validation (Part 1): Appropriate Material Selection And Part Design
3/29/2018
Several key areas with specific criteria are critical to IQ/OQ/PQ process, yet often overlooked or underestimated. In this segment of the series, we will review some of those important details you should consider during material selection and part design.