This blog post has been created for those who want to learn about the importance of CE Marking. We used Read More

All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDDEV 2.7/1 is the most Read More

Absorbable & Non Absorbable Surgical Suture 510k * In general, clinical studies will not be needed for most surgical suture Read More

What is the FDA Registration number?FDA Registration number provided by FDA soon after the confirmation of registration. This is applicable Read More

The person responsible for regulatory compliance (PRRC) is not intended to take the place of a European Authorized Representative (EC Read More

Device name: Peripheral Vascular Catheters MDR 2017/745: Class: Class III, Rule 8: Implantable device and long term surgical invasive device Read More

The animal testing utilized for the assessment of the medical devices initial evidence of device safety, their potential performance when Read More

Clinical Information system means all data, reports, writings, research, and calculations performed using a medical device in scope. Output is Read More

UKCA Mark or a CE Mark logo is a must depending on which legislation the device has been certified under. Read More