Blog

Standardizing Post-Market Surveillance (PMS)

  • 27. September 2018

Standardizing the Post-Market Surveillance You have a medical device on the market and are subject to Post-Market Surveillance (PMS), right? Well, how do you conduct PMS and is that the industry consent? Soon, these questions can be answered thanks to the new technical report ISO 20416. Drafting ISO 20416, as in its current status as […]

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edge cases of combination products

Edge cases of combination products

  • 30. July 2018

Combination products, as regulated by the US FDA, are ruled differently by the European Commission (EC) and for the latter, lack substantial guidance. This is boiling up again in Europe with the publishing of the Medical Device Regulation (MDR) 2017/745. This article discusses some edge cases of combination products and the restrictions in guidance. Edge […]

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article 117 MDR

Article 117 impact on Medicinal Products Manufacturers

  • 23. July 2018

With the ratification of the Medical Device Regulation (MDR), the change from a directive to a regulation has not only a major impact on the legal and liability aspects for a manufacturer of medical devices, but the regulation applies more stringent control and regulatory scrutiny to products intended to be placed on the EU market. […]

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EU regulation MDR article 117 for combination products

How the EU regulates Combination Products

  • 16. July 2018

With increasing modernization in the pharma and medical device industry, Combination Products are stealing the limelight away from conventionally used medical devices and products. In fact, projecting global sales of $115 Billion, combination products, or named borderline products in the EU, form a vital constituent of medical products. Learn here what the EU regulation on […]

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EU borderline product

All you need to know about Borderline Products

  • 9. July 2018

As the medical and pharmaceutical industry is rapidly being transformed to lend more precision to administering medical and therapeutic products, Borderline Products are becoming more and more the norm. But what is it about these Borderline Products? About Borderline Products To be clear on the terms, borderline products are similarly understood as the combination products […]

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clarifying FDA regulations on combination products

Clarifying FDA Regulations on Combination Products

  • 2. July 2018

Combination Products are, more and more, seen as one of the most potent areas of the pharmaceutical industry. Showing great promise, it is projected that global sales may reach up to $115 billion by the fall of 2019. Proven growth and potential of these products, it has sustained extraordinary levels of the Compound Annual Growth […]

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definition and application of combination product

Combination Products – Definitions and Applications

  • 25. June 2018

First things first: The term Combination Products has been coined by the FDA during the last decade. Synonyms have been used in the industry, such as drug device combination products, drug delivery products or combined products. To separate from other jurisdictions, only the FDA does officially use the term combination product so far. The EU […]

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how drug delivery with combination products work

Understanding drug delivery routes

  • 18. June 2018

Simply put, the process of drug delivery in humans entails introducing medicinal and therapeutic agents into the body. Some primitive examples of drug delivery can be inhaling steam out of a vat of boiling water with herbs to remedy congestion. From this fundamental point, it is essential to understand that advancement in drug delivery mannerisms […]

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Avanti Europe welcomes Diederichs

Avanti Europe welcomes Diederichs Pharma Consulting to the network

  • 17. May 2018

Avanti Europe is very proud to announce the strategic cooperation with Diederichs Pharma Consulting. As Avanti Europe already offers expert consultancy and contracting in the field of medical devices and combination products, the addition of Diederichs Pharma Consulting to the network adds to this strategy. Diederichs Pharma Consulting offers its bespoke service to support its […]

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Avanti Europe as pioneer

Avanti Europe is appointed pioneer by hystrix medical

  • 8. May 2018

Avanti Europe proudly and boldly announces to be appointed Pioneer for hystrix medical. To pioneer for hystrix medical allows Avanti Europe to participate in a novel platform and supporting hystrix medical during the start and evaluation phase. What is hystrix medical? Being the merging node between suppliers and buyers of medical products, implants and related […]

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