OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement...
Requirements
Corrosion and Characterization Methods
Corrosion is a chemical process by which metal, stone, or other materials are broken down via the formation of oxides,...
Applications of Robotics in Healthcare and Medical Devices
The platform of Robotics facilitates automation in any industry. It uses various streams of Engineering including...
Developing Clinical Trials for Your Intended User
For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in...
Understanding DHF’s, DMR’s, and DHR’s
If you are a part of the medical device industry, you are probably familiar with just how many “must know” acronyms...
The FDA Pathway to Generic Drugs
It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not...
The FDA’s Digital Health Center of Excellence Platform (DHCoE)
Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such a...
Deciding The Intended Use Of The Product Under FDA
FDA recently released a proposed rule that amends its existing regulations around establishing the intended use of a...
Meeting FDA Regulatory Requirements While Programming PLCs
Programmable Logic Controllers (PLCs) are the components that are used for interfacing between multiple hardware...
Health Canada Requirements for Face Shields
Health Canada released a new notification on requirements for companies intending to manufacture face shields during...
FDA Plans to Restart Inspections: Update
Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about...
Availability of Notified Bodies for Conformity Assessments
The EU Commission committed to provide information on the availability and the capacity of the notified bodies to...
Ready to learn more about working with us?
