Übersetzung für "Medical device products" in Deutsch

Ursatec Verpackung GmbH stands for innovative developments in preservative-free pharmaceutical, medical device and cosmetic products such as oral and nasal sprays or inhalatives.

In industry, she has collaborated with medical device platform Via Global Health to create an end-user review system that encourages feedback on medical device products, which drives user dictated change in medical innovation.

One of the issues we had to deal with for using a motor in a medical device was medical products approval.

Yoav's wide-spanning career has focused on developing innovative software and medical device products mainly for start-ups and fast-growing companies.

Many pharmaceutical and medical device products listed are available upon prescription from a medical doctor or qualified medical professional only, and not all such products may be available in all countries.

The aim of this article by Dr Sharon Frank is to analyse issues in the pre-marketing phase of medical devices, notably when defining a product as a medical device (c.f. borderline products), the classification of medical devices (categorisation of devices in accordance with their risk), and the role of Notified Bodies in these two issues.

Our experts determine which regulatory requirements apply to each manufacturer based on the countries in which medical device products are registered, sold or planned to be sold.

The guidance for software validation provided by most global regulatory agencies applies to products ranging from software that is in itself a medical device or a component of a medical device, to products that are used in the production and quality control of medical devices and pharmaceuticals.

Founded in 2001, Via Biomedical has core development competencies in catheters, balloons, stent delivery systems, molded medical device products and assemblies regularly used in interventional cardiology, neurovascular, and peripheral vascular markets.

A Centralised Dispute Resolution Procedure for Borderline and Classification Matters The aim of this article by Dr Sharon Frank is to analyse issues in the pre-marketing phase of medical devices, notably when defining a product as a medical device (c.f. borderline products), the classification of medical devices (categorisation of devices in accordance with their risk), and the role of Notified Bodies in these two issues.

In May 2014, the EIB finalised a EUR 100m loan to the Sorin Group, a global medical device company whose products are used to treat over one million patients per year.

Biomet is active in orthopaedic and other medical devices and related products.

He is a certified medical device product.

After all, medical devices and medicinal products are subject to a raft of European legislation.

The company’s production laboratory meets the highest requirements for a medical device production facility.

The same procedure will be used for primary packaging for medical devices and pharmaceutical products and for small packagings.

The products are used in the form of medical devices, biocidal products, medicinal products and cosmetic preparations in various fields of business.

Pamex Pharmaceuticals GmbH is a German manufacturer of food supplements, medical devices and pharmaceutical products.

"This may become increasingly important especially as the nature of the medical device product changes".

This is necessary because – unlike medical devices – lifestyle products are not regulated by special legislation.

There are many similarities to the market access rules for medical devices and medicinal products, which have clear EU regulations.

These may become increasingly important especially as the nature of the medical device product changes.

According to the EU directive, Class IIa medical devices are products intended for long-term continuous use in the oral environment.

The need for rapid legislation in the area of medical devices manufactured utilizing products derived from human tissues or cells is clear if we want to avoid the risk of misuse.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food.

2.6.2 The EESC agrees with the principle that if medical devices contain medicinal products or human blood derivatives or human tissue engineered products "with action that is ancillary to that of the device", the medical devices directives should apply.

The Commission shall be empowered to adopt delegated acts in accordance with Article 21a necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0.1 % by weight) in the Union, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging.';

The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only.

EU legislation that has recently been subject to major revision, in particular the legislation on medical devices, cosmetics, construction products and consumer product safety and market surveillance, is not addressed by the communication.

Union legislation that has recently been subject to major revision, in particular the legislation on medical devices, cosmetics, construction products and on consumer product safety and market surveillance is not addressed by this Communication.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination [13];

This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products.

In particular, that is the case where there are specific, comprehensive legal systems already in place in a sector, as for example in the fields of feed and food, cosmetic and tobacco products, common market organisations for agricultural products, plant health and plant protection, human blood and tissues, medicinal products for human and veterinary use and chemicals, or where sectoral needs require specific adaptation of the common principles and reference provisions, as for example in the fields of medical devices, construction products and marine equipment.

The Commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Community, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging.

This is particularly relevant for new developments in domains concerning biopharmaceuticals, vaccines, antimicrobials, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, biobanks, new medical devices, combination products, diagnostic/treatment procedures, genetic testing, interoperability and e-health, including privacy aspects.