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Medical Devices Regulations Services Available In Austria
34 services found
by:Chemical Inspection & Regulation Service Limited (CIRS) based inHangzhou, CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & Management. Customs Clearance. IPR Protection in ...
Manufactured by:SHL Medical AG based inZug, SWITZERLAND
SHL implements quality management systems throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored internally through ...
by:Emergo by UL based inAustin, TEXAS (USA)
Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We have worked with numerous SMEs and Start Ups to develop their Quality Management System (QMS), Technical File and Risk Management Documentation to help them attain a CE Mark for their new medical device(s) in both a timely and cost-effective manner. We have experience of working with all classes of medical device (Class I, ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR applies to all manufacturers selling medical ...
Manufactured by:DIERS International GmbH based inSchlangenbad, GERMANY
Our competent team of engineers, sport scientists and computer scientists is available for your questions and suggestions. To ensure the quality and precision of your DIERS measuring system, we offer you regular maintance services (according to Medical Device ...
Manufactured by:RUA Life Sciences Plc based inAyrshire, UNITED KINGDOM
Our experts offer a consultancy service, which supports your preparation of medical device files and regulatory proposals. The team is world renowned for this work and have global experience of regulatory ...
Manufactured by:GEOMED Medizin-Technik GmbH & Co. KG based inTuttlingen, GERMANY
Quality and trust - these two terms are utmost important to us. That is why we introduced a certified quality management system early on, which is regularly adapted to current requirements. GEOMED® Medizin-Technik has a certified quality management system in accordance with EN ISO 13485. In addition, our quality management system fulfills the requirements of the European Medical Devices ...
by:TÜV Rheinland AG based inKöln, GERMANY
When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European ...
by:Custom Medical based inDarmstadt, GERMANY
Even though usability engineering has been common practice in other industries for a long time, the question keeps coming up: do I have to do usability engineering as a medical device manufacturer, or is it ...
Manufactured by:EME srl based inPesaro, ITALY
All our products: Have CE brand, indicating that the product is complying with all European directives that regulate its usage; from design, manufacturing to the introduction in the market, putting into service of the product until its disposal. All medical devices respect the requirements of Medical Devices ...
by:Emergo by UL based inAustin, TEXAS (USA)
For many healthcare innovators, opportunities to grow can outpace their ability to scale. Building capabilities in-house requires time and resources that many firms don’t have in the evolving commercial and regulatory demands of the healthcare ...
Manufactured by:Exact Medical Manufacturing, Inc. based inLancaster, NEW YORK (USA)
At Exact Medical, we treat every project with the same unwavering commitment to quality. Our systematic approach to quality assurance gives Exact Medical the confidence that every step - from material sourcing, validation, production and packaging to delivery - is precise and achieves our customers’ expectations. We can say with confidence we deliver the right product every ...
Manufactured by:Eurotape B.V based inSoest, NETHERLANDS
We ensure consistent delivery of products and services that meet the requirements of our customers and strive to achieve complete customer satisfaction while pursuing continuous improvement. ...
Manufactured by:Eurotest Laboratori S.r.l. based inBrugine, ITALY
All devices sold in the European Union must comply with the relevant product directives and have CE ...
Manufactured by:LRE Medical based inNoerdlingen, GERMANY
Always conscientious and quality-conscious: We completely meet our customers’ needs by providing them tailor-made solutions, designed and engineered to always be compliant with regulatory standards. In our fullservice approach that extends from the initial idea to the finished, validated diagnostic device produced in series, we exhibit utmost flexibility. This includes flexible project ...
Manufactured by:BYTEC Medizintechnik GmbH based inEschweiler, GERMANY
We advise you fully in all matters relating to your medical device - regulatory, technical and economical - during all stages of the product life cycle. ...
by:Orthogonal based inChicago, ILLINOIS (USA)
Drastically Reduce Time to Market & Adapt to Change Faster Than Your Competitors. Orthogonal applies Agile software development methods to medical device software development, allowing us to move faster while still delivering the quality, safety and reliability your device ...
by:BSI Consulting based inHerndon, VIRGINIA (USA)
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
Manufactured by:Egemen International based inIzmir, TURKEY
PMS (Post Marketing Surveillance) activities consist of a process in which the performance and safety of medical devices are continuously monitored after the supply of products to the market. The necessity for post-market monitoring of a medical device begins immediately after the medical device is placed on the ...