Search Results for ISO

Showing 1 – 25  of 29

Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap By Dieter Schlaps - Published 28 February 2017

This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs

Tags: ISO, ISO IDMP, Identification of Medicinal Products

Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World By Dieter Schlaps - Published 21 December 2016

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

Categories: News, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Drugs

Tags: ISO IDMP, IDMP, Identification of Medicinal Products

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Tags: ISO 13485:2016, Quality Management System

ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning By Michael Mezher - Published 23 September 2016

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.

Categories: News, FDA, ISO, Medical Devices

Tags: ISO 13485:2016

European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs By Zachary Brennan - Published 13 May 2016

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.

Categories: News, Europe, EC, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: medical device manufacturing standards, device manufacturing, ISO standards

ISO IDMP: Another Compliance Project or a new way of Conducting Business? By Rune Bergendorff - Published 19 April 2016

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.

Categories: Features, Europe, EC, EMA, Drugs, Labeling, Packaging

Tags: IDMP, ISO, Identification of Medicinal Products, Regulatory Information Management

New ISO 13485: Device Companies Have Three Years to Transition By Michael Mezher - Published 01 March 2016

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.

Categories: News, Japan, Canada, Europe, Oceania, US, ISO, Medical Devices, Quality

Tags: ISO 13485, ISO 13485:2003, ISO 13485:2016, Quality Management Systems, QMS

European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015) By Nick Paul Taylor - Published 14 January 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, ISO, MHRA, Clinical, Drugs, Medical Devices

Tags: HRT, ovarian cancer, ISO, ANSM, Danish Medicines Agency

FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP By Michael Mezher - Published 18 December 2015

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.

Categories: News, US, CDRH, GHTF, IMDRF, Audit, Medical Devices, Postmarket surveillance, Regulatory strategy

Tags: MDSAP, Medical Device Single Audit Program, ISO 13485, Kim Trautman

FDA Warns Cancer Center Over Unsanitary Conditions By Michael Mezher - Published 11 November 2015

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.

Categories: News, US, FDA, Compliance, Prescription drugs, Manufacturing

Tags: Form 483, Warning Letter, Johnson Memorial Cancer Center, ISO 7, ISO 5, HEPA Filters

Bringing Structure to Substance Information By Niels Henriksen - Published 28 August 2015

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.

Categories: Articles, Features, ISO, Active pharmaceutical ingredients, APIs, Postmarket surveillance

Tags: pharmaceuticals, pharmacovigilance, International Organization for Standardization, ISO, Identification of Medicinal Products, IDMP

ISO IDMP - Putting the Pieces Together for Investigational Data By Dorte Frejwald Christiansen - Published 10 August 2015

This  article reviews the European Medicines Agency (EMA) Master Data Management Roadmap (MDM), the role of the European Union Drug Regulating Authorities Clinical Trials database (EudraCT) and the European Union (EU) portal in regard to investigational  product information.

Categories: Articles, Features, Europe, EMA, ISO, Research and development

Tags: investigational data, clinical trials, pharmaceuticals, ISO, International Organization for Standardization, IDMP, Identification of Medicinal Products

IMDRF Proposes QMS Principles for Software as a Medical Device By Michael Mezher - Published 08 April 2015

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.

Categories: News, GHTF, IMDRF, ISO, Manufacturing, Medical Devices, Project management, Quality

Tags: Software as a Medical Device, SaMD, ISO 13845:2003, QMS

Going Digital: EMA to Ditch Paper, Require Electronic Application Forms By Michael Mezher - Published 26 February 2015

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.

Categories: News, Europe, EC, EMA, ISO, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, CTD, electronic application forms, eAFs, eSubmissions Roadmap, ISO IDMP

With Eye on Improving Quality, Indian Regulator gets First ISO Certification By Michael Mezher - Published 24 February 2015

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).

Categories: News, India, CDSCO, ISO, Government affairs

Tags: ISO, International Organization for Standardization, ISO 9001:2008, ISO 9001, Quality Management Systems, QMS

EU Task Force to Implement New Drug Identification Standards By Michael Mezher - Published 23 February 2015

The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs.

Categories: News, Europe, EMA, ISO, Drugs, Postmarket surveillance

Tags: ISO, IDMP, XEVMPD

EMA Explains Centralized Product Database, Talks Future Changes By Michael Mezher - Published 18 February 2015

The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA).

Categories: News, Europe, EMA, ISO, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, EudraVigilance, XEVMPD, ISO IDMP

India Seeks Input on Draft Revisions to Device GMPs By Louise Zornoza, RegLink News - Published 04 December 2014

India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act, which describes good manufacturing practices (GMPs) for medical devices.

Categories: News, India, CDSCO, Compliance, In vitro diagnostics, Manufacturing, Medical Devices

Tags: Reglink, Schedule M-III, GMP, ISO 13485

Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter By Alexander Gaffney, RAC - Published 22 July 2014

Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.

Categories: News, US, CDER, Compliance, Drugs, Quality

Tags: Pharmaceutical Compounding, Compounding, Sterile Compounding, ISO 5, Cleanroom, Asceptic, Aseptic, Particleboard, Warning Letter

Public Comment Period Opens on ISO 9001, Major Device Quality Standard By Alexander Gaffney, RAC - Published 21 July 2014

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.

Categories: News, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Quality

Tags: ISO 9001, QMS, Quality Management System, Consultation, International Standards Organization, ISO

Quality Concerns Lead to Suspension of all Products Manufactured by Canadian Company By Alexander Gaffney, RF News Editor - Published 11 February 2013

Categories: Health Canada, Quality

Tags: ISO 13485

ISO Releases New Voluntary Anti-Counterfeiting Standard By Alexander Gaffney - Published 05 September 2012

Categories: ISO

Tags: ISO 12931, Anti-Counterfeiting, Counterfeiting, Standard, Latest News

Risk Management for Medical Devices - A Practical Approach By Val Theisz - Published 22 June 2012

Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission. After recognizing that the risk management process itself is deficient, should you bite the bullet and address this more fundamental issue first, but risk delaying the submission in exchange for mid- and long-term benefits? If you decide this is the best course of action for you and your company, this article is for you.

Categories: Features

Tags: ISO 14971, Design History File, Risk Management File, 510(k), risk, medical device

ISO Releases New Device Standard for Toothbrushes By Alexander Gaffney - Published 30 April 2012

Categories: ISO

Tags: Teeth, ISO 10126:2005, ISO 10126:2012, Tooth Brush, Toothbrush, Tooth, Mouth, Standard, Latest News