SW FOR MEDICAL DEVICES

Better Compliance and Faster Results

Date: 24.-25.10.2011
Location: Rantasipi Airport Congress Center, Robert Huberin tie 4, 01510 Vantaa
Price: FiHTA members 500€, non-members 750€ Register by: 19.10.2011

Course objectives:

To give you hands-on understanding of current software guidelines and standards for compliance with regulatory demands
To give you examples of efficient implementation to achieve compliance
To give you some hints on future trends in the medical device software area.

Agenda:

Day 1: 8:30 – 17:00

Day 2: 9:00 – 14:00

Registration & Coffee

Introduction and Regulatory Overview

Intent & History
Expectations of the FDA, EU and Japan
Regulation, Standards and Guidance
Enforcement

SW lifecycle - Introduction and Background

Types of lifecycles
Elements and concepts for effective and •compliant lifecycle processes
62304 Background and Scope
62304 Software Safety Classification Requirements

Requirement management

Formal requirements
Techniques for requirement
management
Effective implementation

Software risk management

Formal requirements
Risk management techniques
Traceability
Effective implementation

Q&A

Early QA techniques in agile environments

Formal requirements
Static testing
Test Driven Development
Design-by-Contract

Continuous integration

Efficient testing techniques
Regulatory requirements
Test techniques
Exploratory testing
Effective implementation

Exercise

FTA/FMECA
Risk Measures
Requirements
Verification

Q&A

Course instructor: Robert Ginsberg, Senior SW consultant, Synergus AB

Course fee (1,5 days): For FiHTA member companies 500 euros/participant. For non-FiHTA members 750 euros/participant. VAT 23% shall be added to the fee. If there is three or more participants/company reduction of 50 euros/participant shall be granted. The fee includes: lectures, course materials, coffee and lunch on both days.

Registration: Submit the registration form by September 24th, 2011.

Cancellation policy: Cancellation of registration prior to the commencement of the event: 7 days or less, 50 %. If no cancellation, full fee.

For more information: terhi.kajaste@teknologiateollisuus.fi, tel: +358 50 576 5536

Rights to changes reserved.

Wellcome!

Jaa linkki

Toimipisteet

Suhdanteet ja tilastot

Suhdanneraportit ja tilastot

Teknologiateollisuus ry, Eteläranta 10, PL 10, 00131 HELSINKI, Puh. (09) 192 31, faksi (09) 624 462 Copyright (c) Teknologiateollisuus ry 2012

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