Industry Perspectives
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FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices
7/26/2021
On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.
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Retro-Validation: 6 Factors To Resolve Validation Deficiencies
7/19/2021
A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.
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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
7/14/2021
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
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Emerging Technologies In The Delivery Of Proteins & Peptides
6/28/2021
The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.
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Data Integrity In Supply Chain Risk Management During Zero Trust
6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
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What Do Artificial Intelligence And Continuous Validation Have In Common?
6/2/2021
Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.
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The Role Of The Contract Manufacturer Under The EU MDR & IVDR
5/31/2021
As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.
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Dental 3D Printing: Disruptive Trends In The Digital Dentistry Market For 2021
4/21/2021
Dental 3D printers have experienced a surge in popularity in recent years, reflecting the increasing range of applications and opportunity for revenue generation offered by these systems. How does this market look for 2021, and what is the one dental device disrupting the market?
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How To Increase Your Medtech Growth Trajectory In Indirect Markets
4/12/2021
In emerging as well as mature markets, we have seen the rise of smaller, more agile partners specializing on a specific sector or market segment. Since the vast majority of the growth in sales is expected to happen overseas, it is obvious that having an optimized indirect sales strategy will be instrumental to deliver results. But how do we evaluate potential channel partners? Read this article to find out!
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Establishing An Effective Calibration Program
3/15/2021
Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.