Easy Global Training Entered an Agreement with Johnson & Johnson to Support Their Clinical Evaluation Review Updates to Become Compliant with MEDDEV 2.7.1 Rev 4
As of Aug 22, 2016, Easy Global Training entered an agreement with Johnson & Johnson to Support Their Clinical Evaluation Review Updates for their Orthopedics devices to become compliant with MEDDEV 2.7.1 Rev 4 for European Union market authorization.
The MOUNTAINEER Laminoplasty System is an implant system that consists of screws and various sizes of plates to address the needs of the surgeon and patient as necessary. Per its Information For Use document (IFU), “the MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures.” “The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.” “Laminoplasties are done to treat the following conditions (Pohl, 2015; O’Brien, 1996; Yonenobu and Oda, 2003):
- Ossification of the posterior longitudinal ligament (OPLL) over multiple levels with maintained cervical lordosis
- Congenital canal stenosis with maintained cervical lordosis
- Multilevel cervical spondylosis with maintained cervical lordosis
- Posterior compression from ligamentous hypertrophy with maintained cervical lordosis.”
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Easy Global Training is based in Potomac, MD in the United States. It is a leading, up-to-date information network in the fields of Regulatory Affairs, quality compliance, and medical affairs for life sciences (drugs, excipients, devices, and combination products), food & food ingredients, dietary supplements, and complementary / alternative medicine. Our portfolio of products includes webinars (live and on-demand), e-learning self-paced modules, in-class training, white papers, e-books, guidelines, best practices, reports, job aids, and e-newsletters. We also provide social media channels with webcasts and interviews from the industry experts, as well as academic and regulatory body experts on regulatory training and quality compliance hot topics, best practices (GMP, GDP. GCP. GLP. GVP, …), guidelines, and regulations at a global level. For your convenience, we also provide a variety of forms and templates across these fields. Easy Global Training strives to provide a wide network of high-quality resources that are up-to-date and to communicate new updates as well as new insights and competitive points of view. This is a collaborative platform, designed for professionals across a variety of fields to learn and share valuable information related to the latest laws, policies and regulations, while ensuring continuous improvement in global operations, regulatory training, quality compliance, and safety.
