em-tec GmbH was Established in 1989 near Munich. Given that this time We have now designed and developed effective products and solutions approved for medical know-how together with for industrial use.
Whether or not you're starting up the certification system, looking to transfer or perhaps will need to discuss selections for your enterprise, Get in touch with our pro crew who'll guide you thru the procedure.
Grievances have to tie into Hazard Management. Did the grievance discover a whole new hazard or dangerous situation not captured? Does the incidence of hurt align with That which you believed?
Together with ISO 14971, there are many other vital medical gadget market criteria requiring danger administration. The partial list involves:
The thought of a threat / benefit Assessment is this: the medical great things about the medical unit outweigh the residual threat.
Employing greenlight.guru’s software permits you to conveniently hyperlink Danger Controls to certain Layout Controls (and This can be the only Resolution readily available on the market for this).
On completion of the 2-day course, individuals should be able to Consider the challenges with the usage of Agile tactics and be ready to adapt these procedures hop over to here as wanted to guarantee the a knockout post event of compliant, safe, and effective items.
This class builds around the ideas in AAMI TIR45:2012, Steering on using agile techniques in the event of medical system software
On this webinar, we’ll take a look at the offered basic safety and good quality knowledge sources, what they can tell us, challenges with examining the data, and what you can do to overcome these issues and help you in your role.
For me, it's very intriguing to look at and listen to feed-back and opinions regarding the subject within the Views on the authorities, the regulators, the consultants, and medical unit firms.
For those you can find out more who’re on the regulatory crew and presently marketing in many nations, heed this webinar for the many nuances and dates for taking care of criteria in many jurisdictions.
 A few of the subject areas for being coated are: validation and requalification; validation experiences, protocols, and documentation; product or service adoption; troubleshooting; approach variations and procedure equivalency; solution launch solutions; and optimization of sterilization process.
As one of the main notified bodies for CE marking, we could assist you on choosing the most economical conformity assessment routes to accomplish CE marking.
For just a dangerous condition to take place, there has to be a foreseeable sequence of functions that result in this.