Blog Posts

Future Outlook: Phase Change Materials Market Size, Share, and Growth Projections

Posted by Animesh Rao on September 19, 2024 at 2:48am 0 Comments

Phase Change Materials (PCMs) are substances that absorb, store, and release large amounts of latent heat during phase transitions, typically from solid to liquid or vice versa. They are widely used for thermal management as they help regulate temperature by absorbing excess heat and releasing it when temperatures drop. In terms of value, the phase change materials market is estimated to grow from USD 628 million in 2024 to USD 1,383 million by 2029, at a CAGR of 17.1%. The market report… Continue

Ist es für Erwachsene gesund, mit Puppen zu spielen? Eine psychologische und soziale Betrachtung

Posted by gutdolls on September 19, 2024 at 2:43am 0 Comments

Ist es für Erwachsene gesund, mit Puppen zu spielen? Psychologische, emotionale und gesellschaftliche Überlegungen

Das Spielen mit Puppen wird oft als eine kindliche Aktivität betrachtet. Viele Menschen assoziieren Puppen mit der Kindheit und sehen sie als Spielzeuge, die dazu beitragen, soziale und kognitive Fähigkeiten bei Kindern zu fördern. Doch in den letzten Jahren ist das Interesse an Puppen auch bei Erwachsenen gestiegen, insbesondere im Zusammenhang mit Liebespuppen oder…

Continue

Understanding the Importance of a TEC Certificate: A Comprehensive Guide

Posted by Saba Khan on September 19, 2024 at 2:37am 0 Comments

In today's increasingly international market, firms must adhere to a wide range of regulatory norms, particularly when working with technology and telecommunications equipment. The TEC Certificate is an important credential in this regard. This article takes a comprehensive look at what the TEC Certificate is, why it is required, and how it benefits businesses and consumers.

What is the TEC Certificate?

The Telecommunication Engineering Centre (TEC) certificate is a mandated…

Continue

Are You Ready for the New EU Medical Device Regulation?

All those in medical device industry must be aware that MDR (EU Medical Device Regulation) which was postponed for implementation due to corona pandemic. The due date in now approaching fast which is May 26, 2021. So, are you prepared all device manufacturers who are selling in Europe?
We are sure that you must be aware that changes between old MDD (Medical Device Directive) and MDR are significant and lot of new requirements have been added. (Its four times longer than MDD)
New changes are in consideration of new development that is happening in medical device industry. More stress has been given on safety and Efficacy.
Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2020 to comply with the new regulations. Which was extended till May 2021.

Now let us know broadly what way industry get affected.
Is Your Product Existing or New?
Existing Product:You need to have additional of documentation as per MDR requirement as product is already in Market and proven. The term UOUP (User Interface of unknown Provenance) is used for existing (the product which is in market before February 2015 with no major design changes) Design changes needs to be reviewed that may impart it to NON UOUP status. This depends on type of design change.
New Product This will be treated as non UOUP product.
MDR requires compliance with International standard on usability engineering (IEC 62366-1:2015) This is different for different types of devices. MDR to scrutinise the devices as per this standard.
In Brief UOUP demands documentation,
1, Standard human factor like User specification, Intended use and user environment.
2. Use related risk analysis. If any minor design change then, additional risk analysis for that change.
3.Post Marketing surveillance data are UpToDate.
(Human factor validation study may not be needed.

Additional need in Non UOUP devices: User interface specification that requires labelling and training as well as testable technical requirement linked to user needs.
Depending on classification human factor validation will be needed.

There are many detailed things whether product needs to be tested in Europe like US FDA needs testing in USA. Are not discussed in this blog.

Note following broad guideline for approach.

IZiel Healthcare has collaborated with Belgium based Obelis (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. This collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking of global medical devices through technical support, consultancy, representation, and device registration services.

Views: 1

Comment

You need to be a member of On Feet Nation to add comments!

Join On Feet Nation

© 2024   Created by PH the vintage.   Powered by

Badges  |  Report an Issue  |  Terms of Service