Search

The pre-filled syringe industry is rapidly expanding, with a projected compound annual growth rate (CAGR) of 13.9% between 2021 and 2028 (1). Fill/finish is an intricate process requiring many steps [...]

'Compliance Case Studies' discusses compliance situations useful to practitioners in compliance and validation. Each case presented deals with a specific compliance problem, elements of which are described to demonstrate to [...]

'Engineering for Non-Engineers' discusses science and engineering principles associated with equipment, utilities, facilities, and associated GMP systems useful to practitioners in compliance and validation. We intend this column to be [...]

The Food and Drug Administration promulgated regulatory requirements that manufacturing companies have to comply. Continuous improvement using six sigma is a means to meet ISO requirements and the cGMP or current good manufacturing practice. Optical Integrity Inc.Es compliance requirements matrix is also presented.

The effect of the implementation of the Food and Drug Administration's pharmaceutical regulation 21CFR11, on the adherence to federal laws by the pharmaceutical and medical equipment industries, is described.

Few methods are suggested for analyzing the performance of a medical equipment company. Various qualitative issues concerned with the evaluation of financial statements and manufacturing activity are also suggested.

INTRODUCTION Not all medical devices require clinical investigation in order to demonstrate their safety and efficacy. But, even for some class II medical devices that can be cleared by the [...]

Staff The U.S. Food and Drug Administration (FDA) is promoting how knowledge acquired in the development, manufacture, and use of one generation of product can be applied to future generations [...]

International report Mindray Medical updates recent, projected launches of products A Medical Device Daily Staff Report Mindray Medical International (Shenzen, China) has reported updates on new product launches and its [...]

Physio-Control says it's on track to resume full shipments by April A Medical Device Daily Staff Report Physio-Control (Redmond, Washington), which makes Lifepak brand defibrillators, confirmed earlier this week that [...]

Today's MDD food for med-tech thought 'We want to cooperate both with our government, the Chinese government, and the Chinese medical device industry to try to assist the Chinese for [...]

Firms continue to stumble over QSRs, design validation issues BY MARK McCARTY Medical Device Daily Washington Editor WASHINGTON — The Quality Systems Regulations (QSRs) that FDA uses to help device [...]

Viasys secures ISO certification Viasys Healthcare (Conshohocken, Pennsylvania) reported that its Viasys Respiratory Care subsidiary has been audited by the British Standards Institution and awarded certification under International Organization for [...]

You simply need to observe what is literally 'the sharp end' of health care - ie where patient meets surgeon - to note that the sector is subject to lead [...]

Avenue Mould Solutions was one of the first companies in Europe to achieve certification to the EN ISO 13485:2003 Quality Management System for manufacturers of medical devices. With extensive experience [...]

International report Omnicell establishes unit in India for quality and R&D A Medical Device Daily Staff Report Omnicell (Mountain View, California) reported the formation of Omnicell Corp. (India), a wholly [...]

Boston Scientific issued 2nd Vaxcel device warning letter A Medical Device Daily Staff Report The FDA has warned Boston Scientific (Natick, Massachusetts) for a second time over poor oversight of [...]

Times are changing in the high precision and complex world of medical implant and component manufacture, with new trends and materials prompting a tooling re-think Once upon a time the [...]

Guidant to establish panel to recommend reporting guidelines By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In an apparent bid to boost its image in light of its recent [...]

New group conducts quality survey with CLMA members As one of its starting points, the Institute for Quality in Laboratory Medicine (IQLM) commissioned a survey conducted by the Clinical Laboratory [...]

IQLM pursues a separate lab report card at 1st conference BY KAREN YOUNG Medical Device Daily Staff Writer ATLANTA - The Institute for Quality in Laboratory Medicine (IQLM) met for [...]

Cyberonics hit with 2nd warning letter from FDA A Medical Device Daily Staff Report Cyberonics (Houston) reported that it received a warning letter, its second in three years, from the [...]

In the wake of 1999's Institute of Medicine report on medical errors, calls are rising for more action, mostly through the Food and Drug Administration, to reduce errors associated with [...]

SMLX (OTC BB: SMLX), a Hallandale Beach-based bio-engineering company, announced the company has been served with a one-count 'Information' as the result of a government investigation concerning a former product [...]

With an ever-growing demand for health care operations, there is an increasing need for new design and manufacture of medical instruments. Companies need to be able to keep supply up [...]

1. Introduction The medical equipment and assistive device industries assume an important role in supporting medical care and health in Japan, where the population is rapidly aging amid a falling [...]

Bespak Ltd. (Buckinghamshire, United Kingdom) is a manufacturer of specialty medical devices for inhaled drug delivery and anaesthesia. The company manufactures more than 450 million complex devices each year, many [...]

The implications of quality management issues within European Commission's Advanced Therapy Medicinal Products Regulation, for medical equipment sector, are presented.

San Jose Medical Center began a formal CQI initiative in 1991 with several management projects. As a result of work done in our emergency department, which analyzed our Patient Call [...], In the hospital environment, vendors supply a wide range of items, from surgical sutures to the latest in high-cost technological equipment. Also, many clinical and support services, such as respiratory therapy, transctiption, and computer databanks are now outsourced to commercial vendors. Interaction with such vendors is often less than satisfactory, with prolonged timelines and disruption of an important process that is being computerized. Although hospitals deal with very few vendors in long-term relationships, such as those seen in manufacturing, this should not preclude the formation of a supplier-customer relationship that goes beyond management's interaction with the sales representative in response to a request for proposal This is especially true when a process improvement team has studied an internal process and defined a key quality characteristic.

Actor, screenwriter and director Woody Allen once said: 'If you're not failing every now and again, it's a sign you're not doing anything very innovative.' That's a difficult statement with [...]

[ILLUSTRATION OMITTED] Changing suppliers is never easy, being both costly and time-consuming. Nevertheless, when you're a small manufacturer, without the influence and purchasing power of larger companies, supply chain management […]

While the European union's Restriction of Hazardous Substances directive has garnered the lion's share of compliance headlines this year, regulatory compliance is second nature in many manufacturing industries. Food manufacturers, […]