Medical regulatory words: compliance, standards, policies and regulations

Health technology solutions – product development and commercialization

Medical regulatory words: compliance, standards, policies and regulations
Unlike many other products, health technology products like medical devices, supplies and software, and advanced therapy medicinal products (ATMPs) are tightly regulated and controlled by the authorities. Up-to-date knowledge of regulations, requirements regulations and standards is important for all those working in the field, as they apply to products throughout their life cycle.

This study module gives you extensive and comprehensive knowledge how to design, manufacture and place on the market health technology products to the global healthcare market, as well as related regulations, requirements and standards.

Join this study module to deepen your skills!

Why participate?

When health technology products are developed and commercialized, the requirements, standards and regulations in different markets like USA, EU, China and Japan need to be considered – from research and development phase to marketing and after sales services. If you are or will be part of any kind of company in biomedical or health technology field, you will benefit greatly from this study module.

On 26 May 2021, the EU Medical Device Regulation (MDR) will become fully applicable, following the transition period, and the EU In-vitro Diagnostic Medical Devices Regulation (IVDR) have to be complied by 26 May 2022. These regulations require all companies to have a “Person responsible for regulatory compliance” whose required expertise in the field can be verified. This person also has significant responsibilities and obligations in quality management matters.

We have built this study module to offer a formal additional education for this profession. The study module includes 2 compulsory courses and 2 optional courses of which you may choose only 1. Each course is worth 5 ECTS. To complete the study module, you must finalize at least 3 courses (15 ECTS).

To qualify for the certificate, you must have a university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline or 4 years of professional experience in regulatory affairs or in quality management systems on medical devices. After completing the study module, you will receive a certificate to prove your competence. Additionally, a work-based training is required to achieve the qualification to work as a regulatory compliance person.

This module is compiled of 4 courses which all can be carried out also separately. If you also want to apply for the other optional course, notice that there is an extra course fee added to the study module’s price.

Tämä on yrityksille hieno mahdollisuus lisätä oman henkilöstönsä osaamista, iloitsee Terveysteknologia ry:n toimitusjohtaja Saara Hassinen.

– Asetusten toimeenpanossa nousee huoli osaajien riittävyydestä, koska säädösten myötä valmistavan yrityksen on nimettävä säännösten noudattamisesta vastaava henkilö, jolla on merkittävät vastuut ja velvollisuudet myös laadunhallinta-asioissa, Saara Hassinen sanoo.

Here you can find all the courses and this study module