Medical Equipment: Todorka Zivreva

Todorka Zivreva 08417

Overview
The medical equipment industry has been rapid changes in the past five years driven by changes in both technology and treatment protocols for patiens. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

A medical equpment is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutal drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as detailed below. The medical devices are included in the category Medical technology. There are so many medical devices, which are so important in our lifes.

Patients who have ever had a knee implant or worn a catheter know firsthand how implantable medical devices have become a way of life for millions. But what makes such devices compatible with the human body? How do device makers ensure that the implants they market will not be rejected by the body’s immune system?
Some people are sceptical, but some find their hope in medical devices so they can have a healthy life.

The Journal of Medical Device Regulation (JMDR) is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing medical device Regulatory Affairs review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents.

The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. The primary language of the medical device regulatory affairs Journal is English but abstracts of key articles are provided in a number of other languages. Feature articles in other primary European languages will also be included from time to time.

The Journal has a Bookstore featuring publications on medical device regulation and related topics, and an industry events calendar.

Validation in the pharmaceutical and medical device industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manifacturing Practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: