Published 29/11/2024

Selenium Medical will exhibit at MedFit 2024

Join Selenium at booth B9 at Medfit 2024 !

Join Us in Lille to Discover Our Services and Innovative Solutions on December 3-4, 2024

Selenium Medical Exhibiting at MedFit 2024

We are delighted to announce our participation in MedFit 2024, a key event for healthcare and biotechnology professionals, taking place at Lille Grand Palais on December 3-4, 2024.

Selenium Medical will be exhibiting at stand B9. This event offers us a unique opportunity to meet with our current partners, connect with new industry players, and showcase our expertise in subcontracting solutions.

Why Visit MedFit 2024?

MedFit is one of Europe’s leading events dedicated to fostering collaboration among players in the medical device, biotechnology, and diagnostic industries. It provides an ideal platform to:

Discover cutting-edge solutions and groundbreaking innovations.
Engage with experts and thought leaders in the field.
Build strategic partnerships around innovative projects.

For the 2024 edition, MedFit will feature:

30+ countries represented
90+ exhibitors
70+ international speakers
20+ innovative projects showcased

Visit Us at Stand B9

Our team will be delighted to welcome you, share our expertise, and discuss your projects. We support you throughout the entire lifecycle of your medical devices, from development to market launch, through our four core areas of expertise:

Plastic Injection: Manufacturing, assembly, and packaging in an ISO 7 cleanroom environment.
Surface Treatment: Anodizing, electropolishing, passivation, laser marking, masking, and automated sandblasting.
Sterile Packaging: Cleaning, assembly, kitting, and packaging in a cleanroom.
Consulting, R&D, Regulatory Affairs: Research and development, manufacturing engineering, validation & verification, laboratory testing, and regulatory and compliance support.

To schedule a meeting or learn more about our participation, feel free to contact us today. Stay updated with our latest news by following our LinkedIn page.

We look forward to seeing you at MedFit 2024 for two days of insightful exchanges and innovation. Visit us at stand B9!

Published 14/11/2024

Successful Inspections: ISO 13485, FDA & ANVISA

Selenium Medical renews ISO 13485 certification and successfully passes FDA and ANVISA Inspections.

Selenium Medical: ISO 13485 Audit and FDA & ANVISA Inspections

At Selenium Medical, we are committed to ensuring the quality and safety of the medical devices we outsource on behalf of our clients. Our production processes and services are rigorously controlled and adhere to the strictest standards, ensuring safe and reliable products for patients and healthcare professionals. You can download our certification here.

ISO 13485

We have recently renewed our ISO 13485 certification, a key standard for quality management of medical devices. This certification is essential for obtaining the CE mark. In this way, it ensures that medical devices meet the safety and performance requirements of the European market. The renewal underscores our ongoing commitment to maintaining high standards of product quality and safety.

FDA (Food and Drug Administration)

As part of an FDA inspection for Premarket Approval (PMA) for one of our clients, we achieved a result with zero non-compliances. This inspection is critical for obtaining market authorization for a medical device in the United States. It validated the conformity of our practices with the FDA’s strict requirements for Good Manufacturing Practices (GMP) and risk management.

ANVISA

We recently reached an important milestone with our first ANVISA inspection, conducted by the Brazilian Health Regulatory Agency. The inspection went smoothly and was carried out for one of our clients with the aim of marketing medical devices in Brazil.

Committed to ensuring the quality and safety of medical devices

These successive achievements highlight the commitment of Selenium Medical and its teams. We maintain high standards of quality and safety and comply with the most stringent regulatory requirements. This also demonstrates our ability to provide our clients with reliable solutions that meet the most complex regulatory demands in an international environment. We remain fully committed to the continuous improvement of our practices in order to support our clients and their projects and contribute to patient safety worldwide.

For more information about our services or to discuss your projects, please feel free to contact us. Additionally, you can follow us on LinkedIn to discover our latest news.

Published 05/11/2024

Selenium Medical at COMPAMED 2024

Selenium Medical will be at Compamed 2024.

Join our team from November 11 to 14 at Compamed 2024 in Düsseldorf, Germany.

Join Selenium Medical at Compamed 2024

We are renewing our participation in Compamed 2024, one of the largest international trade fairs dedicated to medical technologies. This essential event will take place from November 11 to 14 in Düsseldorf, Germany. It gathers key players in the medical device sector, and we will be there to share our services and innovative solutions. Visit our team in Hall 8B at Stand G10-3 to discover how Selenium Medical supports medical device manufacturers at every stage of their product development.

Discover Selenium Medical’s expertise at Compamed 2024

Selenium Medical brings its expertise and experience to medical device manufacturers. We offer a turnkey support from the development phase to time to market. Our holistic approach provides complete support tailored to the unique requirements and challenges of the medical sector.

Join us at Stand G10-3 in the France Pavilion to explore our complete offering covering four key areas:

Clean room Plastic Injection
We ensure manufacturing, assembling, and packaging in clean room (single-use instruments, medical device accessories, custom packaging, medical devices, etc.).
Surface Treatment
We offer various processes, including chemical, electrochemical, mechanical, and marking treatments for the surface processing of implants and surgical instruments.
Clean room Packaging
We provide cleaning, decontamination, assembling, kitting, and packaging in clean rooms for devices, as well as labeling and sterilization management.
Consulting, R&D, and Regulatory Affairs
Our team of experts supports our clients from the development to the certification of their medical devices.

We invite you to meet our team to discuss your projects and discover how we can contribute to your success. Our experts will be available to answer all your questions and present our innovations in packaging and surface treatment for the protection and quality of your surgical implants.

For more information about the event and registration details, we invite you to visit the official Compamed website.

Additionally, to stay updated on our latest news, feel free to connect with us on LinkedIn. Finally, don’t miss the opportunity to engage with us; contact us now to schedule a meeting on-site.

Published 17/09/2024

Selenium Medical at NASS 2024 : Focus on spine

Selenium Medical is pleased to announce its participation in NASS 2024, an international event dedicated to innovation, research, and education in spine care. The event will take place from September 25 to 28, 2024, in Chicago.

NASS 2024: The first event in the field of spine care

The North American Spine Society (NASS) is a leading organization that brings together global experts in spine care. Each year, it attracts over 9,000 spinal specialists from more than 70 countries. This 39th edition of NASS promises once again to provide a prime setting to explore the latest advancements in spine care. With a rich program of conferences, workshops, and surgical demonstrations, this conference offers a unique opportunity for participants to stay updated on medical and technological innovations.

Meet Selenium Medical at NASS 2024

Selenium Medical will be at booth 2117 during this major event. Our experts will be available to present our innovative solutions for surface treatment and medical device packaging. Discover our innovations including SoBliss®, SoEasy®, and StarSurf®, designed to enhance the performance and safety of medical devices.

You will also learn about our services in cleaning, decontamination, assembly, and packaging. As well as our surface treatment and chemical processes (anodizing, electropolishing, passivation, robotic blasting, nanomordanting, masking, and laser marking). Additionally, we offer comprehensive support covering all stages of your product’s lifecycle, including R&D, manufacturing engineering, standards and regulations, and validation and lab testing management.

Don’t miss out on this key event in spinal care! Join us in Chicago to explore the latest innovations and technologies transforming the industry. For more information about the event and registration details, visit the official NASS 2024 website.

Published 02/07/2024

15 years of evolution in the medical devices sector

This year is a special moment for Selenium Medical: we’re celebrating our 15th anniversary! Since our foundation in 2009, we have evolved and grown significantly in the medical devices sector.

Continuous growth

Since our inception, Selenium Medical has enjoyed remarkable growth. With a clear vision of becoming a key player in the medical device field. Always with the aim of helping to improve patient well-being and medical practices. Today, we operate in four main business areas, across several market segments, and have 100 dedicated collaborators. Our services are used by 231 customers in 11 different countries.

Innovation at the heart of our development

Innovation is a driving force at Selenium Medical. Guided by the goal of preventing infections through intuitive solutions for patient well-being. Our path has been marked by constant progress. With 10 patents to our name, we have constantly pushed back the boundaries to offer cutting-edge solutions. Our achievements include innovative packaging such as SoBliss®, SoKlean® and SoEasy®. Tailor-made to enhance the visibility of your brands and products, while protecting the sterility, functionality and availability of your medical devices. Our StarSurf® nanoetching process, which improves the wettability of titanium implants, also represents a significant advance. Our commitment to quality and innovation has been recognized by 6 international awards.

Diversified expertise

Over the years, we have enriched and diversified our expertise. The strength of our teams lies in their transversal knowledge of medical devices. These cover surface treatment, plastic injection and packaging. With the ultimate aim of guaranteeing patients’ well-being. Today, our services are organized around four main activities: cleanroom plastic injection, surface treatment, cleaning and assembly, and sterile and non-sterile packaging. Finally, thanks to the expertise of our teams, developed from our own products and processes, we cover all stages of medical device development. We offer customized support, including R&D, consulting, qualification and validation of special processes and associated tests. Furthermore, through the development of these 4 activities, we have broadened our scope to meet the needs of different sectors such as orthopedics, dentistry, soft tissue, robotics and in vitro diagnostics.

A human adventure

However, beyond numbers and technology, Selenium Medical’s evolution is above all a human adventure. Our successes are the fruit of the hard work of our teams, the confidence of our customers and the support of our partners. We would like to thank all those who have contributed to this wonderful adventure.

We look back on 15 years of challenges, major innovations and sustained growth. As we celebrate this anniversary, we look resolutely to the future, ready to continue evolving, contributing and innovating to meet tomorrow’s needs.

To keep sharing our evolution, follow us on our LinkedIn page.

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