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.
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.
Books by Dr. Shruti Bhat: http://www.drshrutibhat.com/books
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