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Labeling and IFU Compliance Soon to Follow EU MDR Transition

February 22, 2021
OTC

Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helped them in organizing the labeling and instructions for use associated with their medical devices....

EU MDR Transition, General Labeling Requirements under EU, Medical Device Labeling, Medical Device Labeling Regulations, medical device labeling requirements, medical device labels

Regulatory Intelligence is a key to Quality and Safety

January 29, 2021
Standards

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

Regulatory Affairs, Regulatory Changes, Regulatory Database, Regulatory Intelligence, Regulatory Intelligence for Biopharma, Regulatory Intelligence for Cosmetics, Regulatory Intelligence for Food Supplements, Regulatory Intelligence for Medical Devices

Clinical Intelligence for better Clinical Trials

January 29, 2021
Diagnostics

Every sector including healthcare is based on data nowadays. The only issue with healthcare is the complexity of the clinical data. The constant regulatory changes added with the rising competitions...

Clinical Intelligence, Clinical Intelligence in Clinical Trials, Role of Clinical Intelligence:

FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during COVID-19 Emergency

April 2, 2020
Medical Device

FDA issued this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency. The Agency...

European Medicines Agency Issued Electronic Certificates for Medicines

April 2, 2020
Standards

European Medicines Agency (EMA) has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates...

Medical Device Change Control Process

March 30, 2020
Medical Device

Globalization of the market has greatly enhanced competition and pressure on manufacturers to develop new and high-quality products faster at a low cost. To stay competitive, manufacturers should be...