OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement...
EU
What is ISO 13485?
A Quality Management System (QMS) is a necessity for all organizations, not just companies that are in the...
EU’s New Guidance on Harmonized Standards
The EU Commission released a new guidance document clarifying the purpose of harmonized standards under the EU Medical...
The SWIXIT Dilemma for Medtech- Part II
The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away now....
The SWIXIT Dilemma for Medtech – Part I
Now that the world is done dealing with the Brexit drama, there is more on the plate for the EU Commission. The EU...
Legacy Devices Under EUDAMED
Almost after a year-long delay EUDAMED is finally here and has launched its first of its six modules in December 2020....
Application of Harmonized Vs Latest Version of Standards
Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the...
MDSAP Reports for EU Surveillance Audits
The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and...
EU Commission’s Draft Standardization Request
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics...
What is Design of Experiments?
Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics...
Everything You Need To Know About The UKNI Mark
The Brexit has not only impacted Britain and the EU, it has made changes to the Northern Ireland region as well. As...
What You Need to Know About the UKCA Mark for Your Medical Device
The long-awaited Brexit is set to take place on December 31st, 2020. This is when Britain will exit the European Union...
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