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Quality Control & Compliance

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Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

Compliance Corner Combination Products Enforcement
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Random Checks Now Routine: China To Inspect Your Factories Near And Far

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

China Manufacturing

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

Risk Management Standards

The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

Risk Management Standards

Crosswalk: ISO 14971:2007 Vs. ISO 14971:20XX

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

Risk Management Standards

'Implant Files': New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Implant Files International

FDA's Maisel Updates Industry On Maturity Model Pilot, Facility Inspections, MDSAP

US FDA device center official William Maisel offered an update on the agency’s ongoing efforts at an industry conference last week, touting recent successes in Medical Device Single Audit Program (MDSAP) expansion and its Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

FDA Quality

Adverse-Event Reporting Failure Leads To Guilty Plea For Olympus, Exec

Olympus Medical Systems and a former senior executive have pleaded guilty to allegations that they sold duodenoscopes even after failing to submit required adverse-event reports on them.

Legal Issues Enforcement

EU UDI Deadlines, Documents And Planning: What Does Industry Need To Know?

Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.

Compliance Regulation

US FDA Report Confirms Duodenoscope Contamination Risk

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

Quality Control Safety
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