A Guide to Medical Device Labeling Requirements

As an indispensable part of the medical device that ultimately ends up on the market, labeling is subject to FDA quality assurance requirements. These relate to the materials, operations, and controls of your labeling process, as well as the manner of application, inclusion in packaging, and other factors. To produce compliant labels, manufacturers have to manage, track, and update a significant amount of data.

The Essential Guide to ISO 14971

The International Organization for Standardization created ISO 14971 to assist medtech manufacturers in developing processes for evaluating, monitoring and controlling the risk that their products could cause harm to patients, operators, or other individuals. ISO 14971:2019 is the third and most recent edition of the standard.

FDA’s Quality Metrics Reporting Update March 2022

On March 9, 2022 FDA provided an update on the Quality Metrics for Drug Manufacturing initiative. “FDA established a docket to solicit comments on changes to FDA’s previously proposed quality metrics reporting program (QM reporting program).”

21 CFR Part 314 Checklist (with XLS Download)

Learn more about why and how the FDA regulates pharmaceutical manufacturers, and how the approval process works. You'll also find a download for a 21 CFR Part 314 Checklist to help you stay on course while navigating your way through all of the necessary steps for approval.

QMS and the ICH Q10 Pharmaceutical Quality System

The stakes for quality management are high when it comes to the life science industry. As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The key framework for creating a QMS that can handle the demands of the pharmaceutical industry is the International Conference on Harmonisation (ICH) Q10 model.

5 Necessary Steps for Building a Risk Assessment Framework

The life science sector is one of the country’s most lucrative industries. It’s currently worth $7.7 billion and is expected to attain a CAGR of 7.8% between 2021, and 2028.  But with huge rewards come huge risks, and the life science industries are abundant with them. From global volatility, intellectual property theft, to strict and...

Top 10 Medical Device Testing Companies of 2021

The medical device industry includes a wide variety of life-saving and quality-of-life-promoting tools and technologies. The range stretches from ophthalmic, orthodontic, and orthopedic devices to active implant, in-vitro diagnostics, and other breakthrough innovations. To ensure the effectiveness and safety of medical devices, national and international regulations must be complied with before these finished products and...

6 Steps to HIPAA Risk Assessment Success

Healthcare and life sciences entities, beware. With the increased digitization of medical records worldwide comes a surge in data breaches. Ransomware was the #1 cybersecurity threat in 2021 against the healthcare industry. Healthcare cyber attacks increased by 50% in 2020, and there is a 75.6% chance that at least five million records will be breached...