Medical

First Steps to Medical Device Manufacturing

Network: 
First Polymer Training Skillnet
Duration 2 Days
Course Fee €795. Inclusive of course manual, lunch and refreshments.
Enrolment and Start Dates Comment 25th - 26th March 2013
Course Content Introduction to Medical Device Manufacturing
Training Benefits will include:
* An overview of the medical device sector in Ireland / Globally
* Explanations regarding the regulations that govern the sector
* ISO 13485 - what is it?
* FDA - who are they and what do they require?
* Typical work practices required of operators
* Expectations for technical, scientific and management staff
* What is it like on the inside of a facility?
* Medical Devices in operation
* What are Class I, II and III devices?
* Typical employment conditions
* The controlled environment and room classifications
* Device ideas? - How they make it onto the market
* Device Design Systems
* Basic Problem Solving Techniques
* Good Manufacturing Practice.

Every participant will have the opportunity to identify their key requirements in advance of the course.

Who should attend?
Personnel who have minimal knowledge of the Medical Device Manufacturing sector and working environment but would like to understand what is expected. Suitable for personnel who may be interested in joining or converging with the medical device sector or for those who have just joined and would like a broad overview of the requirements.

Further Enquiries Tel 090 6471223
Fax 090 6471221
Email: info@firstpolymer.com
Location of Course First Polymer Training Skillnet
Course Web Page: 
http://www.firstpolymer.com/first-steps-to-medical-device-manufacturing/
Available to Job Seekers: 
Yes
Certified: 
No

Patient Moving & Handling

Network: 
Rural Enterprise Skillnet
Duration 1 day
Number of Places 10
Course Fee €40.00 - €60.00 approximately
Subjects Taught Patient Moving and handling.
Enrolment and Start Dates Comment Enroling early January for mid January / February training
Course Content Employers / employees responsibilities, bio mechanics, risk assessment and skills demo.
Careers or Further Progression Qualifications beneficial for work in the health care sector.
Entry Requirements Over 18, health care qualification or interest in.
Further Enquiries Gerry Gallagher
Network Manager
Mob: 087 685 8550
Tel: 071 985 8252
Fax: 071 985 8252
E-mail: reskillnet@medpartnership.com
Eligibility Employed, limited places for unemployed on occasions.
Learning Outcomes The learner should be able to demonstrate competence in the subject matter.
Methods of Assessment Learner record, skills demo.
Trainer Various
Location of Course Tuam , Galway
Available to Job Seekers: 
Yes
Certified: 
No

Medical Devices & Diagnostics Future Leadership Programme 2013 / 2014

Network: 
Life Sciences Skillnet
Duration 8 Days over a period of 4 months
Course Fee €1,750.00 per person
Subjects Taught • Personal Development
• Strategy
• Clinical Anatomy / Mechanisms of Disease and Applied Pathology
• Diagnostics / Clinical Trials
• Regulatory Affairs
• Marketing
• Innovation
• Finance
• Employment Law
Enrolment and Start Dates Comment This year's IMDA MedTech Leadership programme will take place over 8 days between October 2013 and January 2014.

Start Date 14 - 16 October 2013, Galway

Royal College of Surgeons in Ireland (RCSI)
18 & 19 November 2013, RCSI, Dublin

20 - 22 January 2014, Galway

Financial Support Free to Job Seekers
Course Content The Irish Medical Devices Association (IMDA)'s MedTech Leadership Programme has been developed by IMDA members over the last five years to provide the industry in Ireland with VALUE for money training at the HIGHEST level of quality.

Aimed at senior to middle management in the medical devices and diagnostics sector within Ireland and fully accredited by the Institute of Leadership and Management (ILM) the programme covers Personal Development, Strategy, Innovation, Clinical Anatomy, Clinical Trial Management, Marketing, Finance, Employment Law and Regulatory Affairs.

Burren Panoramic Suite, Radisson SAS Hotel, Galway:
Personal Development
Strategy, John Lynam, Thomas International

Royal College of Surgeons in Ireland, Dublin
Clinical Anatomy, Physiology and Cardiology, Professor Clive Lee, Professor of Anatomy, Royal College of Surgeons in Ireland & Royal Hibernian Academy; Dr Christian Gulmann, Consultant Histopathologist, Beaumont Hospital; Dr Jacqueline Daly, Division of Biology / Department of Anatomy, Royal College of Surgeons;

Diagnostics and Clinical Trials, Professor John G Kelly, School of Pharmacy, Royal College of Surgeons; Marie Mellody, Irish Clinical Research Infrastructure Network (ICRIN) Coordinator.

Regulatory Affairs,Albert Theatre, Royal College of Surgeons

Burren Panoramic Suite, Radisson SAS Hotel, Galway:
Marketing, Professor Andrew Ainslie, UCLA
Innovation,Professor Andrew Ainslie, UCLA
Finance & Employment Law,Shone, Director, Invisio; and Brid Gannon, Peopleskills Consultant

Further Enquiries Michelle Reinecke-Quain
Life Sciences Skillnet Administrator
Email: michelle.reinecke-quain@ibec.ie
Phone: 061 431802
Learning Outcomes Attendees on this programme will receive an Institute of Leadership Management Endorsed Award (ILM).
Methods of Assessment Exams
Trainer IMDA
Location of Course Galway
Royal College of Surgeons in Ireland, Dublin
Available to Job Seekers: 
Yes
Certified: 
Yes

Biological Evaluation of Medical Devices ISO10993

Network: 
Life Sciences Skillnet
Duration 1 Day
Time: 9:00 - 17:00
Course Fee €200 per person
Subjects Taught Topics covered:
- Biological evaluation and essential requirements of the Directive of Medical Devices
- Structure of the ISO 10993 series
- Risk management and biocompatibility, the process of biological assessment (ISO 10993-1)
- Classification of products
- Selection of tests
- Characterisation materials (ISO 10993-18&19)
- Characterisation of “extractables” & “leachables”
- Preparation of samples (ISO 10993-12)
- Cytotoxicity, irritation/reactivity, sensitisation, acute systemic toxicity
- Systemic toxicity subacute/subchronic/chronic (ISO 1099-11)
- Implantation tests (ISO 10993-6)
- Hemocompatibility (ISO 10993-4)
Enrolment and Start Dates Comment 1 Day Event on:
19th June 1 Day
20th June 1 Day
Course Content This course provides an overview of the biological evaluation of medical devices following the guidance contained within the ISO 10993 series. It offers a first-hand look at how to plan and conduct the biological evaluation of a medical device, and, more importantly, how such an evaluation sits within the activities of design control and risk management by giving practical hints for the definition of pathways based on scientific rationales. The course led by our toxicology expert in Eurofins Biolab will also give the opportunity to bring your specific questions along to the course for discussion and to help to determine a resolution in order to enhance the learning experience.
Further Enquiries michelle.reinecke-quain@ibec.ie
www.lifesciencesskillnet.ie
Learning Outcomes Course outcomes:
At the end of the course, delegates will gain a detailed knowledge of:
• Biological evaluation of medical devices within a Risk Management Process
• Key points of the ISO 10993 series of standards
• Appreciation of testing required
• When to test, and when not to test
• How to deal with process failures
• How to plan and undertake a biological evaluation of a medical device.
Trainer Speaker:
Ing. Paolo Pescio, Medical Devices & Toxicology Manager in Eurofins Biolab.
With a degree in Biomedical Engineering, Paolo is Chairman of the UNI U4201 Committee for non-active medical devices for transfusion and biological evaluation and is also active as a member of ISO TC194 and CEN TC206 groups. He has successfully performed several
relevant training activities in Italy and abroad.
Location of Course Ballybane Enterprise Centre
Galway
Course Web Page: 
http://www.lifesciencesskillnet.ie/IBEC/Events.nsf/wvIMDASNPages/Event~biological-evaluation-of-medical-devices--iso-10993-19-06-2013?OpenDocument
Available to Job Seekers: 
Yes
Certified: 
No
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