How to Make Your Legacy Devices IVDR Compliant? 8-Step Guide
Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if...
Surgical Bandage Manufacturing Business: Process & License
Surgical bandages are low-risk non-invasive medical devices that do not directly sustain or support life. Additionally, their potential harm to patients is minimal. They are primarily used for external wound protection and healing. Hence, they are placed under limited...
Starting a Medical Examination Gloves Business in India
Medical examination gloves play a vital role in the healthcare industry. They serve as a protective barrier that prevents the transmission of infections between patients and healthcare workers. Gloves also protect healthcare professionals from occupational hazards in...
Medical Device Benefit-Risk Analysis: Process & Best Practices
Medical device benefit-risk analysis is a structured evaluation of whether the clinical benefits of a device outweigh its residual risks. It is mandated under ISO 14971:2019, FDA regulations, and EU MDR. Thus, it is critical for regulatory approval, patient safety,...