Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry. Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech […]

The ISO 13485: 2016

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. […]

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists. In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales. London’s […]

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance. What makes preparing premarket submissions that win regulatory approval […]

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is […]

Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s. Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code […]

ISO 14001 –the management’s responsibilities

ISO 14001 –the management’s responsibilities ISO 14001 deals with an organization’s environmental policy.  This instrument has been designed to ensure that organizations achieve and demonstrate sound environmental performance. An organization has to assess the impact of its business on the environment and shape its environmental policy accordingly, so that it contributes to sustainable development. Management’s […]

Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices. […]

The ISO 13485 -what is it?

The ISO 13485  For anyone in the medical devices industry; the real buzzword perhaps is ISO 13485:2003. What is it? How does it matter to the industry? What are its exceptions? The medical device industry, given its enormous impact on human health and welfare; is highly regulated all over the world. In the leading blocks, […]

DME’s help improve the quality of the patient’s life at home

Description: The patient must be incapable of performing routine activities without the DME  What is a DurableMedical Equipment? Introduction Any medical equipment used in the home in order to help in a better quality of living can be called as durable medical equipment (DME). This includes iron lungs, oxygen tents,power scooters, Nebulizers, catheters, hospital beds, […]