OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement...
EU MDR
What is ISO 13485?
A Quality Management System (QMS) is a necessity for all organizations, not just companies that are in the...
Pharmaceutical Temperature Mapping
Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...
A QMS Should be Unique, not Universal
Implementing a Quality Management System (QMS) affects every aspect of an organization, including meeting quality...
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...
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...
Adverse Event Reports for Devices Under an EUA
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the...
Post-Market Clinical Follow up Studies Under EU MDR and IVDR
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices...
EU’s Revised Policy for Combination Products
The EU commission released a guidance document this week that explains the commission’s policies for transitioning of...
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