The European Union Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directives (AIMDD), introducing several significant changes in the regulations. One of the key elements that has been replaced is Essential Requirements (ER). ER have now been replaced by General Safety and Performance Requirements (GSPR).
- May 30, 2023 Medical Devices
- May 26, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter.
- May 26, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
The expanding global footprint of pharmaceutical manufacturers brings about great opportunities, but it's not without the challenges faced by pharma companies in drug development. Compliance hurdles in emerging markets are causing a stir.
- May 26, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Medical Writing
Regulatory writing essentially means developing various Regulatory documents for submission to Health Authorities (HAs). The documents must follow the relevant guidelines and convey the essential information accurately, transparently, and clearly to reviewers. Regulatory medical writers play a significant role in preparing documents and ensuring that they are accurate, concise, and compliant with the prevalent standards.…
- May 25, 2023 Medical Devices
Introduction
Work instruction guides are written documents that provide you with clear and precise instructions on how to perform specific tasks or activities. They are designed to reduce the risk of failures, damages, or inconvenience that may result from improper execution.
- May 25, 2023 Medical Devices
A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:
- May 25, 2023 Medical Devices
What is Staff Augmentation?
- May 25, 2023 Medical Devices, Regulatory Affairs
As we all know, to place an In Vitro Diagnostic (IVD) device in the European Union (EU) market, manufacturers must abide by the EU IVD Regulations (EU IVDR) 2017/746. One of the key requirements of the IVDR cycle is performance evaluation. The objective of performance evaluation is to demonstrate that the IVD is safe and effective to use, and at the same time, it is aligned with its intended use.
- May 25, 2023 Medical Devices, Regulatory Affairs
Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography.
- May 23, 2023 Pharmaceuticals, Regulatory Affairs
Introduction
The European Directorate for the Quality of Medicines and Healthcare recently announced an update on their (CEP) process, called promises to be more efficient, transparent, and user-friendly than its predecessor. In this blog, we will explore the benefits of and the role of Regulatory vendors in helping pharmaceutical companies navigate this new system.