by Hamish Forster | Aug 2012
In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the key elements required within technical documentation in order to demonstrate conformity to the Medical Device Directive (MDD) 93/42/EEC. A key requirement is post-market su ... Read more »
Basic Anatomy of a Design Dossier
by Hamish Forster | Mar 2011
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical ... Read more »
Original equipment manufacturers (OEMs) of orthopedic medical devices are facing cost pressures like never before. To reduce cost and make their products more attractive to reimbursement-restricted purchasers, OEMs are curtailing the size of their sales force and the commissions they pay out; establ...
Regulatory Approval Testing of Hydroxyapatite – The Benefits of Using One Supplier
Gaining and maintaining regulatory approval of medical devices and materials, such as Hydroxyapatite (HA) can be a fraught, lengthy and complex process. Submission of data to regulatory bodies, for example the FDA (Food and Drug Administration), has to be credible and fully documented in order to en...
Orchid Orthopedic Solutions Blog
Welcome to the Orchid Orthopedic Solutions Blog. Our new blog will include spotlights on our manufacturing facilities and employees, news and events regarding the medical device industry, trade show schedules and career opportunities. ...
Jewel Precision began manufacturing innovative custom sterilization case systems in 1984. Jewel Precision's experience in sterilization case manufacturing gives us an edge in developing distinctive systems with a combination of material choices, finishes, and product housing features.
