TransChem Environmental LLC TransChem Environmental, LLC (TCE) was founded with the idea of providing the very best service and support possible for businesses requiring hazardous waste management services.
TCE was developed by combining a team of...
ATL Pharmaceutical We specialize in anti-counterfeiting security labels, multi-panel booklet labels, custom die-cut components, disposable medical devices, direct mail, and product labels. Our facility, Quality Management System (QMS), and...
Maxclean Technology Maxclean Technology, Inc. is your source for factory-direct products, specializing in disposables for controlled environments, personal protection and static control. Our ongoing commitment is to provide our distributing...
Accugenix The leader in genetic microbial identification.
Accugenix, Inc. - Provides leading-edge technology in microbial identification and characterization services. Our FDA-registered lab is cGMP compliant and maintains...
Eppendorf With headquarters in New York and over 200 employees, we are the largest subsidiary of Eppendorf AG (Hamburg, Germany)—world-renown manufacturer of the highest quality laboratory instruments and consumables for the life...
Tecan Tecan (www.tecan.com) is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics, and clinical diagnostics. The company specializes in the development, production and...
Liquid handling (LiHa) disposable tips
Tecan offers a wide range of disposable tips for use with the liquid handling (LiHa) arm, on both Genesis and Freedom EVO® series instruments. Tecan Liquid...
Te-MO™ disposable tips
Tecan offers a wide range of Te-MO 96 disposable tips with three different volume sizes, with or without filters.
Formatech Inc Formatech, founded in 1993, provides contract services that deliver unique solutions to our clients’ product development and manufacturing challenges.The company's service offerings include: preformulation and formulation...
Close control of the EtO sterilization process is required to ensure the safety of medical devices. Requirements for validation and control of EtO sterilization have increased substantially in recent years. The ANSI/AAMI/ISO (American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization) 11135 standard "Medical ...
Point Of Care Testing in Clinical Trials – Page 1
Point of care (POC) testing is diagnostic testing performed promptly and conveniently in the vicinity of the patient, avoiding the often lengthy procedure of sending samples to be processed in a central laboratory. This gives rise to the alternative names of near‐patient and bedside testing. The requirement for POC testing is increasing, with the ...
A number of suppliers to the Life Sciences sector claim to have developed applications or solutions that are `compliant' to 21CFR Part 11. Many of these are in fact only partial solutions, do not address fundamental issues of data integrity or do not provide the necessary flexibility to allow for a case-by-case interpretation of the predicate rules.
The completeness of the Part 11 solution is of ...
While “going green” is a recent cliché, it is also a key factor to consider when developing a product or modifying a process. In today's economic climate, the regulated product manufacturer needs to perform a thorough cost-benefits analysis before considering such a change. The obvious benefit of going green is the environmental aspect. However, the potential competitive benefits need to be ...
Potent and highly potent active pharmaceutical ingredients have the potential to cause serious health effects in workers at very low airborne concentrations. The use of containment equipment as part of a systematic approach to potent compound safety is advised to control worker exposure. However the containment performance of equipment can not be assumed, evaluation of containment performance, ...
Managing the Product Record for the Medical Device Industry
“The dynamic medical device and instrumentation market depends on its ability to rapidly innovate its product offerings and, at the same time, support rigorous FDA requirements for electronic documentation. IDC believes that Agile Product Lifecycle Management can help medical device and instrumentation manufacturers develop and maintain ...
Single-use, disposable products were first introduced to the biomanufacturing industry about a decade ago. Until recently, single-use manufacturers had to extol their benefits and virtues to convince biomanufacturers to consider trying them. However, today’s growing biopharmaceutical product diversity, increasing demand, and high development costs are forcing an increasing number of life sciences ...
The voluntary certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products in the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device Directive and In Vitro Diagnostic Directive) ...
The FDA is currently reviewing the 510(k) regulations. The current regulations are designed to assure the safety and effectiveness of medical devices. These regulations govern various aspects of the design, clinical evaluation (where required), manufacturing, packaging, labeling (including promotional information), commercial distribution, and post-market surveillance of medical devices. In a ...
An Oracle White Paper Updated January 2008
PLM technology ensures FDA compliance for medical device companies by providing comprehensive content to support management decisions.
EXECUTIVE OVERVIEW In the medical device industry, efficiently meeting U.S. Food and Drug Administration (FDA) requirements is a key to business success. Product lifecycle management (PLM) technology ensures FDA ...
StudyManager Sponsor Edition (SE) dramatically improves study performance with real-time interaction and clinical data collection for pharmaceutical and ...
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