ProClinical Life Sciences Recruitment Blog

What will happen if you don’t comply with the MDR and IVDR?

Posted by Owen Bach

07/12/17 12:30

Simply put, failing to comply with the new medical device (MDR) and in-vitro diagnostic (IVDR) regulations is not an option for companies that wish to continue developing these devices once the transitional period comes to an end in 2021. The regulations are absolutely critical to the future success of medical devices companies. Here’s why:

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

How to get the right people in place for the MDR and IVDR

Posted by Luke Webber

04/12/17 14:30

In an already competitive market for talent, the task of assembling a highly skilled workforce to carry out your compliance plan for the new medical device regulations will be no easy feat. Getting the right people in place will undoubtedly affect your existing workforce, but the most important aspect to consider will be the additional personnel you’ll need to set your company’s compliance plan in motion. Here are some steps to follow to get the right people in place for the MDR & IVDR:

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Topics: Regulatory affairs, Human Resources, Quality Assurance, Manufacturing

How will the changing role of Notified Bodies after the MDR and IVDR affect your company?

Posted by Owen Bach

30/11/17 12:30

Perhaps one of the most significant changes from the recent EU medical device regulations is the reformed role of Notified Bodies. Previously seen as ‘industry partners’ that would assist medical device companies with compliance and conformity assessments, Notified Bodies will now be the primary enforcers of the new regulations. This is an effort to ensure that they are fully qualified to oversee certified products, and that more emphasis is put on high-risk devices.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

What is the new classification system for medical devices and IVDs following the MDR and IVDR?

Posted by Owen Bach

29/11/17 12:00

In May 2017, the European Parliament published a set of regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) that will require companies to make significant changes to their manufacturing, clinical investigation, quality assurance and data reporting processes. To read more about these transformative pieces of legislation, download our comprehensive guide. This article will explore the impact of the new classification system, for manufacturers of both medical devices and IVDs.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

What you need to know about the changes to EU medical devices (MDR) and in-vitro diagnostics (IVDR) regulations (2017)

Posted by Owen Bach

28/11/17 15:30

The new EU medical device and in-vitro diagnostic regulations are an effort by the European Parliament and Council to improve the manufacture and marketing processes of medical devices to ultimately ensure greater patient safety.

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Topics: Life sciences news, Regulatory affairs, Quality Assurance, Manufacturing

cGMP: What every quality assurance professional needs to know

Posted by Peter Hogg

26/01/15 16:30

With a growing demand to develop new drugs and medicines, quality assurance professionals working in pharmaceutical companies need to stay abreast of the regulations and codes of practice that form part of the drug development process. 

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Topics: Career advice, Training & Qualifications, Quality Assurance, Manufacturing

About this blog

ProClinical is one of the leading recruitment agencies in the life sciences sector. Blogs are written by ProClinical recruitment consultants and experts within the recruitment and life sciences industries. This blog features advice on finding new jobs and career planning, as well as life sciences news and hiring tips for employers.

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