Medical Device QMS: A Guide to US FDA & ISO 13485 Compliance
What is a Medical Device Quality Management System?A Medical Device Quality Management System (QMS) is a formally documented structure of policies, processes, and procedures designed to ensure the safety, efficacy, and quality of a medical device across its entire lifec...
The Ultimate Guide to Clinical Trial Data Management
Behind every approved drug and medical treatment lies a mountain of data. This data, gathered from thousands of patients in clinical trials, tells the story of a drug’s safety and efficacy. But this story must be flawless. Clinical Trial Data Management (CDM) is t...
Regulatory Medical Writing: Key Documents, Guidelines & Best Practices
What is Regulatory Medical WritingRegulatory medical writing involves creating essential documentation submitted to health authorities such as the FDA or EMA for the approval of pharmaceuticals, medical devices, and biologics. This type of writing ensures that clinical ...
Streamlining Country-Specific Medical Device Registrations
Expanding into global markets presents major opportunities for medical device manufacturers, but it also introduces a maze of complex, country-specific regulatory pathways. From CE marking in the EU and 510(k) submissions in the US, to unique requirements in China, Braz...
Enhancing Diversity in Clinical Trials: Strategies and Regulatory Impacts
In recent years, the demand for greater diversity in clinical trials has become a defining issue in clinical research. Historically, clinical trials have been criticized for underrepresenting racial and ethnic minorities, women, older adults, and other underserved popul...
