MPD software validation for medical devices
10 March 2016 ∙ 4 Greenfield Crescent, Edgbaston, Birmingham B15 3BE
Medilink West Midlands, in conjunction with Acclaim Biomedical Consulting, is offering a one day workshop exploring the requirements needed for software development and manufacturing within Medical Devices. With over 20 years’ experience in medical devices, Acclaim Biomedical Consulting is best placed to support and advise on the regulatory processes for existing and new software products and processes.
This course will focus on the regulatory requirements that surround the software that is used and needed in Medical Devices and manufacturing environments. It will touch on the associated standards and how to ensure compliance, with a particular focus on risk management and software lifecycles. We will help you to decide if your software is a medical device as defined by the European regulations and, if so, how to classify it to ensure you comply with the Medical Device Directive. You will also explore how ISO 62366, ISO 62304 and ISO 60601 impacts on software processes and usage and review what regulators will be looking for.
Course content and key topics covered
- Familiarity with the regulatory environment for software products
- Review of software in manufacturing, the issues and practical solutions
- Review of software development, what regulators want
- Familiarity with the standards used
- Risk management and software lifecycle considerations.
Who should attend?
- Medical device manufacturers
- Software managers
- Project managers
- Software engineers
- Regulatory affairs officers and managers
- Quality control officers and managers.
By attending this course, delegates will:
- Understand the regulatory framework for software
- Review the ISO standards and their applicability, including risk management and usability
- Understand the principles of software lifecycles
- Clarify software development and manufacturing requirements.
- Early bird fee: Receive a 15% discount when booking before Friday 29 January 2016
- Member fee: £140
- Non-member fee: £190
To register or for more information, please contact Sarah Wootton on 0121 452 5630 or SarahW@MedilinkWM.co.uk. To book your place, go to the Medilink West Midlands website.