ISO 13485 is the most widely used for medical devices throughout the world; it shapes the quality management systems for medical device manufacturers globally; it applies to design, development, production, installation and servicing of medical devices. This international standard drives customers and competitors to take quality seriously in medical devices design, research, development, and manufacturing. ISO 13485 and compliance is a measure of the ability to meet customer and legal requirements. This course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. This course enables participants to learn about the best practices for implementing and managing medical devices quality management system (MDQMS) as specified in ISO 13485:2016. The participant will learn the different components of a MDQMS such as quality manual, required procedures, records, measuring performance, management commitment, internal audit, management review and maintaining effectiveness. You will be able to:
| Code | From | To | City | Fees | |
|---|---|---|---|---|---|
| ISO05 | 13 Jan 2020 | 17 Jan 2020 | London | US$ 5000 | Register |
| ISO05 | 09 Mar 2020 | 13 Mar 2020 | Bali | US$ 5500 | Register |
| ISO05 | 11 May 2020 | 15 May 2020 | Kuala Lumpur | US$ 4500 | Register |
| ISO05 | 05 Jul 2020 | 09 Jul 2020 | Dubai | US$ 4200 | Register |
| ISO05 | 21 Sep 2020 | 25 Sep 2020 | Barcelona | US$ 5500 | Register |
| ISO05 | 16 Nov 2020 | 20 Nov 2020 | Bangkok | US$ 4500 | Register |
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Certificate of Completion will be provided to the candidate(s) who successfully attend and complete the course. Training hours attendance percentage of 75% is required.
Standard course hours: 8:30 A.M. to 3:30 P.M. Informal discussions: 4:30 P.M. to 5:30 P.M.
We use a blend of interactive and hands-on methods, active participation, a variety of instructional techniques, dynamic presentations, individual and group exercises, in depth discussion, DVD’s, role-plays, case studies, examples. All of the information, competencies, knowledge and skills acquired within our training programs, are 100% transferrable to the participants’ workplace.
Pre-Test and Post-Test Assessment are applied on 5-day and 10-day programs. Also, post course evaluation and candidate’s evaluation are applied to add another level of quality measurement. Candidates’ feedback is highly appreciated to elevate the training service quality.
A- Have staff trained in the latest training and development approaches
B- Support nationalization and talent management initiatives
C- Have properly trained and informed people who will be able to add value
D- Gain relevant technical knowledge, skills and competencies
A- Develop job related skills
B- Develop personal skills in subject matter
C- Have a record of your growth and learning results
D- Bring proof of your progress back to your organization
F- Become competent, effective and productive
G- Be more able to make sound decisions
H- Be more effective in day to day work by mastering job-related processes
I- Create and develop competency to perform job well
A- 10% discount after 05 candidates’ registration.
B- 15% discount after 10 candidates’ registration.
C- 20% discount after 20 candidates’ registration.
D- 25% discount after 25 candidates’ registration.
E- 30% discount after 30 candidates’ registration
F- Higher discount rates will be offered based on work volume with different clients.
A- One extra free seat is offered on 4 candidates on the same course and dates.
B- Two extra free seats are offered on 6 candidates on the same course and dates.
C- Three extra free seats are offered on 8 candidates on the same course and dates.
D- Four extra free seats are offered on 10 candidates on the same course and dates.
E- Five extra free seats are offered on 12 candidates on the same course and dates.
Nominations to our public courses are to be processed by the client’s Training and/or HR departments. A refund will be issued back to the client in the event of course cancellation or seat unavailability. A confirmation will be issued to the relevant department official(s).
If a confirmed registration is cancelled less than 5 working days prior to the course start date, a substitute participant may be nominated to attend the same course or a 20% cancellation charge is applied. In case of a no-show, a 100% fee will be charged.
PAYMENT POLICY
Payment is due upon receiving the course confirmation, invoice and/or proforma invoice. However; the fee due can be wire transferred to our bank account directly after course completion. Our bank details are illustrated on the confirmation, invoice and proforma invoice, as well. The above documents can be communicated electronically, i.e., in a soft copy or/and in hard copy based on customer’s request.
COPYRIGHT
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