The Medical Device definition
Examples of The Medical Device in a sentence
The Medical Device Reporting laws and regulations require that the Company provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of its devices, as well as product malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur.
The Medical Device Reporting laws and regulations require us to provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of our devices, as well as product malfunctions that likely would cause or contribute to death or serious injury if the malfunction were to recur.
The Medical Device Reporting regulation requires that the Company provide information to the FDA on deaths or serious injuries alleged to be associated with the use of its devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the malfunction were to recur.
In addition, for incidents and near-incidents fulfilling the definition of an AE or an SAE, the appropriate pages of the CRF must be completed as described in Section 7.6. The "Medical Device Incident Report Form" should be completed as thoroughly as possible and signed by the investigator or his/her designee before transmittal to Glaxo Wellcome.
The Medical Device Directive (Council Directive 93/42/EEC of 14th June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union.
The Medical Device Software never serves as a substitute for a clinician’s professional experience, judgment and decision-making.
The Medical Device Incident reporting and Post Marketing Surveillance Agreement, the Quality Agreement and the Share Purchase Agreement shall survive pursuant to its own terms after termination of this Agreement.
The Medical Device Directive (MDD) article 10 and MED ▇▇▇ defines an incident as: any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the Instructions for use which, directly or indirectly, led to or might have led to the death of a subject, or USER or of other persons or to a serious deterioration in their state of health (see definition of SAE).
The Medical Device Quality tuition for Europe addresses the responsibilities for the development manufacture and distribution of medical devices per the.
The Medical Device Quality tutor for US defines the individual responsibilities of the parties as music the regulatory and quality aspects of a medical device.