On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices.
The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.
The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.
Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.
The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.
The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.
Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.
"This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients' health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons", said Edith Schippers, Minister of Health of the Netherlands and President of the Council. Details http://www.consilium.europa.eu/en/press/press-releases/2016/05/25-medical-devices/
Shruti U. Bhat, PHD, MBA is a Lean Six Sigma Expert and uses DMAIC and DFSS principles for Innovation, New Product Development and Continuous Improvement. This ensures exponential productivity in research, checks product defects, variations and reworks. Complementing DFSS, she also employs Lean, Quality-by-Design (QbD) and Design of Experiments (DOE) methodologies to develop products faster, cheaper and state-of-the-art in quality.
She leads path-breaking product development programs such as Anti-cancer, Anti- Tuberculosis, Monoclonal antibodies, Pain Management, Vaccines, Biosimilars, Nanotechnology and Platform delivery systems for Pharmaceuticals, OTC, Natural Health Products, Biotech and Medical Devices companies. Her mantra is to "Lean Innovation: Shorten development timelines, Decrease R&D costs, bring products Fast- to- market".
Shruti works with start ups, mid-sized and growing firms and is an invited speaker at several conferences and workshops.
Website: www.DrShrutiBhat.com
Books by Dr. Shruti Bhat: http://www.drshrutibhat.com/books
Contact: http://www.drshrutibhat.com/contact.html
Connect with Shruti on-
Twitter https://twitter.com/ShrutiUBhat and LinkedIn https://www.linkedin.com/in/drshrutibhat
Tags: #ShrutiBhat, #ContinuousImprovementGuide, #LeanSixSigma, #LeanInnovation, #TQM
Shruti U. Bhat, PHD, MBA is a Lean Six Sigma Expert and uses DMAIC and DFSS principles for Innovation, New Product Development and Continuous Improvement. This ensures exponential productivity in research, checks product defects, variations and reworks. Complementing DFSS, she also employs Lean, Quality-by-Design (QbD) and Design of Experiments (DOE) methodologies to develop products faster, cheaper and state-of-the-art in quality.
She leads path-breaking product development programs such as Anti-cancer, Anti- Tuberculosis, Monoclonal antibodies, Pain Management, Vaccines, Biosimilars, Nanotechnology and Platform delivery systems for Pharmaceuticals, OTC, Natural Health Products, Biotech and Medical Devices companies. Her mantra is to "Lean Innovation: Shorten development timelines, Decrease R&D costs, bring products Fast- to- market".
Shruti works with start ups, mid-sized and growing firms and is an invited speaker at several conferences and workshops.
Website: www.DrShrutiBhat.com
Books by Dr. Shruti Bhat: http://www.drshrutibhat.com/books
Contact: http://www.drshrutibhat.com/contact.html
Connect with Shruti on-
Twitter https://twitter.com/ShrutiUBhat and LinkedIn https://www.linkedin.com/in/drshrutibhat
Tags: #ShrutiBhat, #ContinuousImprovementGuide, #LeanSixSigma, #LeanInnovation, #TQM
