Summary of Previous Clinical Experience Sample Clauses

Summary of Previous Clinical Experience. The LiquiBand FIX8® device was CE-marked on 13 June 2014 and since that time, Advanced Medical Solutions Ltd. has conducted Post Market Surveillance (PMS) as part of its obligation to Directive 93/42/EEC Annex II, clause 3 and EN ISO 13485:2016. The PMS process includes the documentation of customer complaints, customer feedback and compilation of any clinical evaluations. Since launch in 2014 until October 31, 2018, out of a total of 46,493 devices sold, 1272 units (2.73%) were associated with complaints of device malfunction and 19 units were associated with complaints of adhesive failure (0.04%). Investigation into the units associated with device malfunction found that these devices were unable to be activated due to a mechanical defect or malfunction, or were unable to deliver adhesive, which did not pose any risk to the patients. In each case of device malfunction, the investigator would be able to use a new device to complete the hernia repair, either LiquiBand FIX8® or another marketed fixation device. Investigation into the devices reported for adhesive failure found no issue with adhesive used in the same lot and reference numbers of devices and it is concluded that these reports were from improper use, or mechanical failure of the device as opposed to adhesive failure. Along with pre-clinical testing, six(6) independent OUS clinical evaluations have been conducted evaluating the LiquiBand FIX8® device for hernia mesh fixation for groin hernia (inguinal and femoral), Spigelian hernia and Inguinal Disruption repair, with four (4) of the evaluations including peritoneal closure [4][5][6][7][9][11]. A combined total of 354 subjects were enrolled in these evaluations for a total of 415 hernia repairs (398 XXXX, 17 TEP) and the device was found to perform as intended with minimal post operative pain and complications (see section 4.0 below for a summary of these evaluations). Additionally, the LiquiBand FIX8® device has been evaluated for use in other non-groin hernia repairs including; Incisional/Ventral, Parastomal, Umbilical, and Hiatal hernia repairs, with minimal complications observed from a total of 64 subjects [12][13][14]. In all evaluations, the Investigators reported that the device was safe and effective for use in abdominal hernia repair.
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Related to Summary of Previous Clinical Experience

  • Recognition of Previous Experience (a) The Employer will recognize recent related RN experience on the basis of one (1) annual increment for each one (1) year of service up to the maximum of the grid. Part-time service shall be recognized on the basis of fifteen hundred (1500) hours paid in previous employment equals one (1) year of service. It shall be the responsibility of a newly hired employee to make a claim of recent and related experience within the probationary period in order to be considered for a salary increment. If she/he fails to make a claim in the specified time period or fails to provide reasonable proof of recent related experience, she/he shall not be entitled to recognition.

  • CREDIT FOR PREVIOUS EXPERIENCE All employees shall be classified according to previous comparable supermarket experience. Previous comparable experience shall be granted on the following basis: A. Out of the industry for less than one (1) year will receive credit for fifty percent (50%) of their previous experience to a maximum credit of twelve (12) months' credit for previous experience. B. Out of the industry for more than one (1) year, will receive credit for fifty percent (50%) of their previous experience up to a maximum of six (6) months' credit for previous experience. No previous experience will be considered unless it has been stated by the employee on his or her Application for Employment form. (This provision shall not apply where employees fail to indicate their previous comparable experience by agreement with Management.) New employees having previous comparable experience may be paid at a lower scale of wage than their claimed experience calls for but not less than the minimum rate established by this Agreement for an evaluation period not to exceed forty-five (45) days from the date of employment, providing that if the employee's services are retained, then after the forty-five (45) day period they shall receive any difference between the evaluation rate paid and the rate for which their experience qualifies them retroactive to the date their employment started, and shall receive written notification showing the credit granted for previous experience. In the event of any disagreement as to the credit granted for previous experience, such disagreement shall be considered a Grievance and the Grievance Procedure provided in this Agreement shall apply. Providing that the Employer has: i) Provided the employee with the "New Employee" letter provided for in Section 3.02 of this Agreement not later than two (2) weeks from the date of employment, and ii) Provided the employee with the written notification showing credit granted for previous experience within the forty-five (45) day period required by this Section, and iii) Provided the Union with a copy of the letter showing credit granted for previous experience within the same period then no consideration will be given to any disagreement pertaining to credit for previous experience if presented later than sixty (60) days from the date of employment.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Previous Experience 31.01 New employees will be classified according to previous comparable experience for the purpose of establishing wage rates. The Co-operative shall not be required to recognize previous experience of new employees who have not worked in the same or similar business in the past two (2) years. Recognized credit for previous experience shall be applicable to qualifying employees commencing with the first working day following completion of said employee's probationary period. 31.02 It shall be the responsibility of the employee to supply proof of their previous experience prior to the completion of their probationary period. Otherwise, all claim for credit for previous experience shall be forfeited by the employee. 31.03 In the event of any disagreement as to credit granted for previous experience, such disagreement shall be considered a grievance, and the Grievance Procedure provided in the Agreement shall apply.

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  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Technical Feasibility of String While ICANN has encouraged and will continue to encourage universal acceptance of all top-­‐level domain strings across the Internet, certain top-­‐level domain strings may encounter difficulty in acceptance by ISPs and webhosters and/or validation by web applications. Registry Operator shall be responsible for ensuring to its satisfaction the technical feasibility of the TLD string prior to entering into this Agreement.

  • Final Evaluation IC must submit a final report and a project evaluation to the Arts Commission within thirty (30) days after the completion of the Services. Any and all unexpended funds from IC must be returned to City no later than sixty (60) days after the completion of the Services.

  • Annual Evaluation The Partnership will be evaluated on an annual basis through the use of the Strategic Partnership Annual Evaluation Format as specified in Appendix C of OSHA Instruction CSP 00-00-000, OSHA Strategic Partnership Program for Worker Safety and Health. The Choate Team will be responsible for gathering required participant data to evaluate and track the overall results and success of the Partnership. This data will be shared with OSHA. OSHA will be responsible for writing and submitting the annual evaluation.

  • Independent Evaluation Buyer is experienced and knowledgeable in the oil and gas business. Buyer has been advised by and has relied solely on its own expertise and legal, tax, accounting, marketing, land, engineering, environmental and other professional counsel concerning this transaction, the Subject Property and value thereof.

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