Product showcase
seal packages, chevron pouches, breather bags, and in select header bag applications. DuraMed’s material uniformity provides an enhanced surface condition able to support high quality image printing. Offering the ultimate in performance and cost savings, choose DuraMed for your future medical packaging needs.
Berry Global
www.berryglobal.com
Corrective and preventive actions in
CAQ.Net
facets of quality management and consists of all components that are necessary to monitor and document the quality of your products.
Thus, in the event of a
CAPA, you can access all quality-related data of a product with just one system and identify the true causes of a quality defect by means of comprehensive root cause analysis. Whether the root cause of the quality defect lies in the purchased raw material, a defective production step, or inadequately trained personnel – you can determine it with just one system.
CAQ AG’s company headquarters in Germany
The concept of Corrective and Preventive Actions (CAPA), required by GMP and numerous ISO/FDA regulations such as ISO 13485 and FDA 21 CFR 820, is a key method of quality assurance in the medical device industry.
CAQ.Net software solutions allow you to put into place a comprehensive CAPA- system in your company, with which you can identify possible causes for quality defects that have occurred, then solve them and adjust workflows, products, or manufacturing processes to prevent the defect from reoccurring. However, the software facilitates much more, as it allows you to not only carry out CAPAs, but also puts a global tool at your disposal with which you can monitor, control, and document your entire quality system – so that the reasons for a possible CAPA can be eliminated as best as possible in advance. The software provides various techniques for different
Since the reason for triggering a CAPA can occur in many different areas, the CAPA functionality in
CAQ.Net is not implemented as a standalone software module, but is available in shape of a cross-modular assistant throughout the entire system. Hence, regardless of where the defect is identified, you can initiate the CAPA process directly in the corresponding module by following a few simple steps in the assistant.
CAQ AG Factory Systems
www.caq.de
A trusted partner for precision parts
Cendres+Métaux, a Swiss manufacturer of high-precision implantable components, has specialised in offering related skills and services to further the market success of its customers. Medical technology developments require the interdisciplinary cooperation of partners with comparably high levels of competence in the field. An important prerequisite is in-depth experience with the rules and prescriptions governing the activities related to the development and approval of medical technology products. In the early stages of such a project, an assessment of the basic feasibility of expectations and of the processes that might be suited to master the production of the desired device often plays a decisive role. This in turn means that a positive outcome of such a project is more likely the earlier in the development process the partners begin to cooperate.
Cendres+Métaux offer expert teams for processes along the value chain.
Sophisticated solutions in the field of medical device implants often require a range of skills that a single company can hardly muster alone. Such developments require close cooperation with partners who offer complementary competencies.
Medical Device Developments /
www.nsmedicaldevices.com
For such endeavours, Cendres+Métaux can contribute a host of very experienced specialist teams along the whole value chain. The number and extent of customer projects that it has been able to foster until market maturity and successful commercialisation underscores its role as a competent and trustworthy partner for new development undertakings. Cendres+Métaux masters the full range of manufacturing technologies in its sector, from basic production processing such as casting, forming, turning, milling or injection moulding through surface treating, cleaning, assembly and packaging to supply chain and E2E (end-to- end) order management.
Cendres+Métaux
www.cmsa.ch
M-ES Series Electronic Valves
Spider technology makes the M-ES series an exceptionally reliable device.
Spider technology is renowned worldwide for exceptional leak resistance and long life. Clippard developed, patented and perfected this technology. Ideal applications have exceeded 1 billion cycles with Clippard’s technology. The M-ES valve accomplishes this by utilising a unique valving principle known as spider technology. This technology has one moving part which moves a mere 0.2mm during operation. This single moving part with a short stroke enables the M-ES series to operate with exceptional reliability. The M-ES series features large cross-sectional o-rings, minimal leak points, and proven poppet designs. All mounting hardware is outside of the flow path for the M-ES and no parts are threaded during assembly to reduce the possibility for contamination. The M-ES has the best performance-to-price ratio for low leak valves. The compact footprint coupled with the long life and exceptional leak resistance make the M-ES line suited to improve reliability in a wide range of applications including biomedical, dental, test equipment, oxygen control, textile, packaging, pressure control, automation and portable systems. Key features include:
■ over 1 billion cycles (under ideal conditions)
■ 0.01 atm sccm leak rate ■ no threads in flow path ■ fast response – 5 to 10ms (nominal)
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