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Medical Device Manufacturing in 2021 – The 3 Key Challenges

Unleashed

Regulations and Medical Device Manufacturing in 2021. Historically regulation of medical devices has lagged the more tightly controlled pharmaceuticals industry. The European Union’s Medical Device Regulation (MDR) – formally known as Regulation (EU) 2017/745 – which sets out rules for medical devices sold in the EU.

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How to Thrive Amid Looming EU Medical Device and iVD Regulations

QAD

The EU Medical Device Regulation (MDR) is set to take effect on May 27, 2021. The EU MDR replaces the EU Medical Device Directive (MDD) , and the replacement of the word “directive” with “regulation” tells the story. Compared to the previous MDD directive, the EU MDR regulations are considerably more comprehensive.

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Patient-centered Care a Focus for Med Device Manufacturers

QAD

In an effort to improve healthcare and support the development of innovative new products, medical device manufacturers are looking more and more at shifting to cloud enterprise resource planning (ERP) solutions for improved device management. The one-size-fits-all approach that may have worked for decades just isn’t as effective today.

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Life Sciences: What’s Changed Post-Pandemic?

QAD

Here are some of the top trends we’re seeing in the life sciences industry post-pandemic: Regulatory : Though new regulations were in progress before COVID, some were delayed, such as the EU MDR and EU iVDR requiring full product traceability from packaging, labeling and manufacturing to post-market and end patient use.

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The Key to Compliance? Build it into Product Design

Oracle SCM

We all know that different states and trading blocs have their own rules and regulations about what can and cannot enter their territories. If a manufacturer’s products are not compliant with the regulations of a state then the customs and excise officers of that state will stop the products entering its territory.

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The importance of a pilot in the solution process

AB&R

Once the equipment is set, we start testing our solution to gather more data and insights into the project. Piloting a solution is important for several reasons, the largest being the success of the project. Don’t just take our word for our Solution Process. The importance of a pilot. What others are saying. Schedule Now. . .

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Arena Solutions and Rimsys Announce Partnership to Offer an End-to-End Quality and Product-Centric Regulatory Solution

Arena Solutions

January 12 , 2021 – Arena Solutions , a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc. , A bout Arena Solutions . Arena Solutions. Foster City, Calif., Foster City, Calif., rimsys.io .

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