New Zealand, EU Agree to Recognize Conformity Assessments, GMP Audits
Devicemakers doing business in both the EU and New Zealand can expect fewer conformity assessment reviews and quality assurance inspections, thanks to a mutual recognition agreement between regulators in the two jurisdictions. The agreement -- which also allows for the exchange of inspection information -- comes as New Zealand is merging its Medsafe agency with Australia's Therapeutic Goods Administration. Devices intended for use in clinical trials are included under the agreement, though it does not currently cover in vitro diagnostic devices. . . .
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IMDRF Draft Attempts to Set Global Standards for Auditors
Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF). Audit results, as well as manufacturer compliance with quality system management requirements and any certifications granted, must be provided to the relevant regulatory agency, the draft states. Auditing organizations must be impartial and independent and not employ anyone affiliated with a device company during three years prior to being hired. The draft, issued late last month, is intended to harmonize medical devicemaker audits across different geographical and regulatory jurisdictions. . . .
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IMDRF to Publish Audit Draft By End of Month: Regulator
The International Medical Device Regulators Forum (IMDRF) has approved a draft document outlining standards for international recognition of groups auditing devicemakers, an FDA official who attended the group's recent meeting in Sidney, Australia, said. "The document should be on the IMDRF.org website by the end of October for comment through the end of the year," according to Kimberly Trautman, associate director of international affairs within CDRH. Developed as part of the Medical Device Single Audit Program (MDSAP), the standard would apply to all auditing organizations that perform regulatory audits of devicemaker's quality management systems, regardless of whether they are regulatory agencies or third-party auditors, Trautman explained. . . .
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Some QMS Audit Lengths to Increase Under New International Standards
Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum (IAF). The document, called MD9, increases the duration of certification bodies' initial QMS audits on average by three days for larger devicemakers and two days for smaller companies, according to Gert Bos, head of regulatory and clinical affairs at the British Standards Institution. . . .
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Virtual Suppliers Inevitable, Require Special Qualification and Auditing
How should devicemakers audit virtual companies that are part of their supply chain? The first step is figuring out who they are, and then tailoring a qualification and audit program for them. Virtual suppliers are so common that devicemakers are likely using them without even realizing it, said John Avellanet, managing director at Cerulean Associates. He spoke at FDAnews’ Supplier Quality Management Congress in Bethesda, Md. Manufacturers should avoid making policies that prohibit the use of virtual suppliers, because they will invariably find that they are in violation of that policy, he suggests. Rather, devicemakers should routinely monitor their suppliers for signs that they have a virtual company in their supply chain. . . .
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GHTF Proposal Could Change the Way You’re Performing Risk Assessments: Find Out How
Cross-border sharing of devicemaker audit results should be easier, thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force's (GHTF) Study Group 3. The proposed document, posted to the GHTF website April 23, does away with the classification of "major" and "minor" conformities and instead introduces a two-step approach to help inspectors determine and communicate the degree of risk associated with a particular deviation. . . .
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Writing an Effective and Meaningful Audit Observation
Steven Sharf, GMP Concepts, says a good supplier audit is actionable, clearly written and meaningful. It enables the supplier that's audited to develop corrective and preventive action plan and it should make readers feel as if they're there at the site. . . .
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