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medical device

This page shows the latest medical device news and features for those working in and with pharma, biotech and healthcare.

FDA moves into crisis mode as shutdown drags on

FDA moves into crisis mode as shutdown drags on

those who will have to work on an unpaid basis – includes an expansion of inspection activities beyond ‘for cause’ inspections to also include “foreign and domestic food, drug, medical, device and ... Also on the excepted activity list is

Latest news

  • Time running out for ‘no-deal’ Brexit medicines laws Time running out for ‘no-deal’ Brexit medicines laws

    for medicines, clinical trials and medical devices are fit for purpose on exit day”. ... The proposals cover medical device regulations too, and the MHRA has suggested that devices that carry a CE mark will continue to be recognised by UK law for a time

  • Medical devices probe uncovers need for “drastic regulatory changes” Medical devices probe uncovers need for “drastic regulatory changes”

    Instead, medical device companies seek approval from one of 58 private notified bodies across the continent in order to gain the CE seal of approval. ... However, if one of these notified bodies deems a medical device unsuitable, then the manufacturer

  • PMEA 2018: celebrating excellence in improving patient outcomes PMEA 2018: celebrating excellence in improving patient outcomes

    Now in its 18. th. year, the awards recognise work done by pharma, medical devices/diagnostics, healthcare agencies/consultancies, patient associations, charities, trade organisations and professional bodies. ... Open to any pharmaceutical, life science

  • Fishawack launches two new divisions, Life partners with hygiene charity and ROAD wins new account Fishawack launches two new divisions, Life partners with hygiene charity and ROAD wins new account

    Partnering with pharma, biotech and medical device clients, Fishawack Medical Communications will develop and deliver services in the fields of med comms, scientific engagement, publications, market access, strategic and thought leader ... The new

  • Digital Trials Digital Trials

    Both medical devices and other grades technology can play a role in digital studies as long as there is a clear rationale for the device selection and sufficient evidence is available ... As a consequence, clinical trials are changing. Digital disruption

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Latest Intelligence

  • Reaching the new influencers Reaching the new influencers

    time for pharmaceutical and medical device companies to rethink and perhaps, transform their Medical Affairs functions. ... In this new age, pharmaceutical and device companies, particularly those innovating and paving their way to scientific leadership,

  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    Unlike PIP, DePuy is not expressly mentioned by the European Commission as highlighting the need for the new Regulations, but is another example of a medical device incident that caused a ... A key change expressly includes software as a ‘medical

  • Pharma’s isolated islands of innovation Pharma’s isolated islands of innovation

    Service design is not part of their core business. And on a broader level, data and digitally-enabled service design by traditional healthcare providers, medical device manufacturers and health insurers has ... The range. of data-enabled medical devices

  • A catalyst for change A catalyst for change

    If any application is filed to launch a drug or medical device in China for the first time, the applicant shall provide clinical trial data on racial differences, if any. ... The Relevant Policies on Encouraging the Innovation of Drugs, Medical Devices

  • Breakthrough innovation Breakthrough innovation

    In doing so, they have tended to adopt development approaches for these products and services that mirror the phase-gate or waterfall approaches used for drug development and traditional medical device

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Latest appointments

  • Dr Martin Rothman joins Sofinnova Partners Dr Martin Rothman joins Sofinnova Partners

    Rothman brings 40 years of experience along with an international network in the medical field to Sofinnova Partners. ... There, he will focus on helping the team identify and evaluate “promising” medical device companies.

  • MedTech Europe appoints new board of directors MedTech Europe appoints new board of directors

    Medical technology European trade association MedTech Europe appointed a new board of directors at its recent general assembly in Brussels, Belgium. ... Michelle Brennan, company group chair for Johnson &Johnson’s EMEA medical device business, was

  • Agios appoints Celgene’s Jackie Fouse Agios appoints Celgene’s Jackie Fouse

    Prior to her tenure at Celgene, Fouse worked for Alcon Laboratories, an ophthalmic pharmaceutical and medical device company.

  • Constellation Pharmaceuticals appoints Emma Reeve as CFO Constellation Pharmaceuticals appoints Emma Reeve as CFO

    Following over two decades’ worth of experience across pharmaceutical, medical device and biopharma companies, Reeve’s most recent role saw her serve as interim chief financial officer and corporate controller of

  • BPR Pharma strengthens research team BPR Pharma strengthens research team

    UK-based international research agency BPR Pharma has appointed Vicky Davies as its new research director following 15 years partnering with pharmaceutical, medical device and consumer health clients.

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