ASPHALION SERVICE “MINI PILL” | MEDICAL DEVICES DEVELOPMENT

Increased complexity in the Medical Devices Development regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.

December 5, 2022

Asphalion’s solutions for Medical Devices Development cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others.

Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning.

Check out our #serviceminipill to see how ASPHALION can help you with the development of Medical Devices!!

For further information, please contact us at: info@asphalion.com

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EC proposal on IVDs Regulation

April 25, 2024

Breaking Regulatory News: European Commission’s Proposal on In Vitro Diagnostic Medical Devices Regulation and EUDAMED Roll-Out

NEWS | High-risk medical devices pilot

April 17, 2024

EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices.

NEWS | New Insight on the Implementation of MDR Article 17

April 12, 2024

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

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ASPHALION SERVICE “MINI PILL” | MEDICAL DEVICES DEVELOPMENT

Increased complexity in the Medical Devices Development regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.

Search

Filter by category

Related news and events

EC proposal on IVDs Regulation

NEWS | High-risk medical devices pilot

NEWS | New Insight on the Implementation of MDR Article 17

ASPHALION SERVICE “MINI PILL” | MEDICAL DEVICES DEVELOPMENT

Increased complexity in the Medical Devices Development regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.

Search

Filter by category

Related news and events

EC proposal on IVDs Regulation

NEWS | High-risk medical devices pilot

NEWS | New Insight on the Implementation of MDR Article 17

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