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    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
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    ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

    Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible. Trautman, who left her position as associate director for international affairs at FDA's Center for Devices and Radiological Health (CDRH) for a position at NSF International earlier this year, was instrumental in writing FDA's 1996 Quality...
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    European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

    In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law. The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation. Background ...
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    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...
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    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...
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    European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer. In the previous product informa...
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    FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

    The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP." ISO 13485:2003 Submission Pilot In 2010, FDA released ...
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    FDA Warns Cancer Center Over Unsanitary Conditions

    The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs. The warning comes more than a year after FDA inspectors visited Johnson Memorial's Enfield, Connecticut site from 16 July 2014 and 5 August 2014. During their inspection, FDA found "serious deficiencies" in the center's practices for producing compounded sterile drugs. The letter lists six ...
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    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
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    IMDRF Proposes QMS Principles for Software as a Medical Device

    In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of “software as a medical device” (SaMD) products. The International Medical Device Regulators Forum (IMDRF) is considering a new document that explores how quality management system (QMS) principles can apply to software as a medical device (SaMD) development. Background IMDRF was formed in 2011 to “accelerate international medical device reg...
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    Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

    In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards. Going Digital The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex.  However, electronic documents provide a num...
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    With Eye on Improving Quality, Indian Regulator gets First ISO Certification

    India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO). In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015. Background ISO 9001 is a set of standards for QMS in organizations where it is imp...