This course provides basic information on regulatory and quality requirements for medical and health technology products throughout the product’s life cycle.

The course introduces the key concepts and definitions in the field and the stages of product development and product life cycle. Versatile product testing, product safety verification and related standards and requirements will be introduced.

Join this course to deepen your skills!

This course is part of Health technology solutions – product development and commerzialization study module. Get acquainted with the study module and other courses included in it. The study module offers a formal additional education for a “Person responsible for regulatory compliance” required by the new EU regulations in Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).

Apply for the course

Teaching begins on the 1st of Septembet. Send your application by the 27th of August!
A maximum of 30 persons will be accepted.

To application form

Here are all the courses and the study module mentioned previously

Health technology solutions – product development and commercialization

Study module - non degree

Content owner
Tampere University

Course dates: 01.09.2020 - 30.06.2021 Type: Continuing Education Extent: 15 ECTS Duration: 10 months City: Tampere
Introduction to quality and regulation for medical product development

Study module - non degree

Content owner
Tampere University

Course dates: 01.09.2020 - 18.10.2020 Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Tampere
Regulatory requirements for design and manufacture of medical devices

Study module - non degree

Content owner
Tampere University

Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Online course, Tampere
Standards, interoperability and regulation in health informatics

Study module - non degree

Content owner
Tampere University

Course dates: 11.01.2021 - 07.03.2021 Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Online course, Tampere
Product development of biomedical devices

Study module - non degree

Content owner
Tampere University

Type: Continuing Education Extent: 5 ECTS Duration: 6 months City: Tampere

Duration

3 months

Extent

5 ECTS

Course dates

1/9/2020 - 18/10/2020

Application period

1/6/2020 - 27/8/2020

Fees

1 400 € + VAT 24 % (Price incl. VAT 1 736 €)

City

Tampere

Faculty or School

Faculty of Medicine and Health Technology

Language of instruction

English

Study fields

Data Processing and Information Technology

Health and Welfare

Management, Administration and Economics

Technology and Natural Sciences

Organising unit

Tree – Continuous Education

Mode of study

Multi-modal teaching

Study level

Other studies

Introduction to quality and regulation for medical product development

Contents

Product life cycle and most common phases of R&D project from research to the product launch
Regulatory framework for health tech products, main standards and regulations in EU and USA and the main parts of the most common quality systems for the medical products
Quality systems for medical and health technology product development. Why it’s needed and how we can use it to improve the product safety?
Medical and health technology products. Definitions, packaging, sterilization, registrations and regulatory.
Most typical tests for electrical and biological safety as well as mechanical and biomechanical testing

Target group

Teaching

The course includes thematic lectures including theory and practice, visitor case presentations and/or interviews, joint discussions and small group works. The course also includes a written learning assignment that can be applied to participants own organization. There is an exam at the end of the course.

The teacher of the course is Timo Allinniemi.

In addition, professionals from health tech companies and organizations are involved.

Course contact persons

Timo Allinniemi, timo.allinniemi [at] tuni.fi (timo.allinniemi@tuni.f)i
Minna Veiranto, minna.veiranto [at] tuni.fi

Contact person

Profile

Teemu Rauhala

Education Manager

Cancellation terms

Application for the training becomes binding after the last application date.

For cancellation made after the end of the application period 50% of the participation fee will be charged.
If the cancellation takes place 1-14 days before the start of the training the entire price of the training will be charged.
In the event of an obstacle the place of training can be handed over to a colleague. The training contact person must be informed of the change in writing or by e-mail.
In trainings with separate selection criteria a place can not be handed over to another.

The cancellation must be made in writing or by e-mail to the contact person for the training.

Register

Introduction to quality and regulation for medical product development

Apply for the course

Here are all the courses and the study module mentioned previously

Health technology solutions – product development and commercialization

Introduction to quality and regulation for medical product development

Regulatory requirements for design and manufacture of medical devices

Standards, interoperability and regulation in health informatics

Product development of biomedical devices

Duration

Extent

Course dates

Application period

Fees

City

Faculty or School

Language of instruction

Study fields

Organising unit

Mode of study

Study level

Course contact persons

Teemu Rauhala

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Introduction to quality and regulation for medical product development

Apply for the course

Here are all the courses and the study module mentioned previously

Health technology solutions – product development and commercialization

Introduction to quality and regulation for medical product development

Regulatory requirements for design and manufacture of medical devices

Standards, interoperability and regulation in health informatics

Product development of biomedical devices