Medical Device Regulations Services
37 services found
by:in2being, LLC based inSaline, MICHIGAN (USA)
The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new ...
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:in2being, LLC based inSaline, MICHIGAN (USA)
At in2being, we specialize in helping both businesses and individuals navigate medical device development and design within the regulatory landscape in the most efficient way possible. in2being’s skilled med-tech professionals are the catalyst that brings customer ideas to life while achieving clearance through the FDA medical ...
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, ...
Manufactured by:Karl Storz SE & Co. KG based inTuttlingen, GERMANY
KARL STORZ has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016. In addition, the system meets the requirements of the European Medical Devices Directive 93/42/EEC Annex II and additional national regulations and legal requirements, such as the Canadian ...
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 ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical ...
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 ...
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:Corpbiz Advisors based inNoida, INDIA
Medical Device Import License in India is managed by the CDSCO, under the Directorate General of Health Services in the Ministry of Health & Family Welfare. To get a Medical Device Import License without any hassle, contact ...
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: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: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: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: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:Busse Hospital Disposables based inHauppauge, NEW YORK (USA)
Medical Device Contract Assembly and Packaging Services; Your medical device assembly, kitting and packaging projects are in our team’s expert hands. Busse offers validated systems for all assembly and packaging tasks so that your project can be completed on time, every time. Learn more about our worry-free medical device assembly, kitting and packaging services. Contact us for more ...