Are you a medical device manufacturer?
According to the new Regulation (EC) 2017/745 on medical devices (MDR), medical device manufacturers must demonstrate to notified bodies that all critical suppliers conform with the ISO 13485 standard covering quality management systems.
As a critical supplier of high-quality toxicological services, SAXOCON is ISO 13485 certified, which means that there will be one less thing to worry about at the next audit.
Having confidence in your suppliers allows you to focus on your manufacturing processes and get your products approved and ready for market as quickly as possible.
Er du den arbejdsmiljøansvarlige hos jer? Har I et værksted, en produktion eller et laboratorie? Og ved du, hvad der er i den luft, I indånder?
Der findes mange arbejdsprocesser, hvor der kan opstå fine og ultrafine partikler, som kan være farlige for jeres helbred.
Hos SAXOCON har vi den nødvendige ekspertise og erfaring til hurtigt at vurdere og løse problemer med uren luft i dit arbejdsmiljø.
SAXOCON is pleased to announce that our CTO, Carsten B. Senholt, will present at the 3rd Cleaning Validation LIVE event on 3 June 2021 at 13:40.
Carsten will introduce the basic principles behind establishing Permitted Daily Exposure (PDE) and its role in supporting cleaning validation in shared facilities.
After more than a year of dedicated effort and nearly 4.000 hours of preparation, we are proud to announce that we have received the globally recognised ISO 13485:2016 certification from BSI under certificate number MD725842.
We chose BSI as our certification partner because they are a well-known and respected provider of certification services and act as an EU notified body for medical devices under MDR/IVDR.
Being a toxicological consultancy company makes us one of only a select few that have obtained this certification.
Achieving ISO 13485:2016 certification is a major strategic milestone in providing our clients with state-of-the-art toxicological and biological safety consultancy services within a quality management context.
SAXOCON is a high-risk supplier for many of our clients and, as such, being ISO certified proves that our consultancy services are built on a foundation of quality processes, encompassing all stages of the value chain from design to final delivery.
We’re just getting started
Obtaining this certificate is not a one-off event. To continue being ISO certified, BSI will audit us on an annual basis. We have committed ourselves to continually investing in the development and improvement of our quality management system.
If you are interested in learning more about how our quality management system can support your business, please do not hesitate to reach out.
We are so very pleased to announce the addition of three new partners. Our highly skilled and valued colleagues Carsten B. Senholt, Kirsten Kling, and Martin Hover are now partners at SAXOCON. This happy news is also an important step in our development as a business.
So, three cheers for our three new partners.
Are you responsible for the production of pharmaceutical products such as vaccines? What if you suddenly find something unexpected? What if there is some foreign material or particles in one of the vials in your production?
Sudden unexpected findings of particulate matter in or in contact with drug products are common in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management of product quality require identifying the root cause and evaluating the impact of findings on product safety. This knowledge is crucial to deciding whether to release or recall affected product batches.
A quick response is necessary when such a finding occurs. Production must be put on hold while the affected lots are identified, and then the hard work of figuring out the type and extent of the problem begins.
SAXOCON has the in-house expertise and experience to quickly assess, process, and help mitigate any unexpected findings.
Are you using 3D printers to produce mock-ups or in manufacturing? What kind and how many particles are produced while using a 3D printer? Particles produced during 3D printing pose a health risk. In fact, they are almost as harmful as the exhaust produced by Diesel motors. Ensuring good air quality and the health and safety of your workplace requires knowing what is in the air you are breathing.
Current rules and regulations for determining air quality use particle mass for determining what level of pollution is acceptable. In fact, the toxicity of a particle is determined by a variety of attributes other than mass. Additionally, the number of particles in a given space plays a role in your exposure. This determines how many particles end up inside you and what the consequences are for your health.
SAXOCON can assess your workspace design on-site, identify sources and measure particle concentrations.
Packaging is not the first thing we think of when we think of food. However, the materials used in food packaging impact the food contained within. So, it is essential to understand the health and safety consequences presented by the food packaging used.
Any materials used for food packaging, known as food contact materials, must be evaluated for their potential for transferring harmful substances to food. Every supplier in the supply chain for food contact materials is responsible for demonstrating compliance with all applicable rules and regulations regarding food contact materials.
SAXOCON can help you ensure that your materials comply with EU and FDA rules concerning food contact materials.
The deadline, 26 May 2021, for EU MDR is fast approaching.
The Danish Medicines Agency (Lægemiddelstyrelsen) recently published guidance regarding the new regulations and their consequences for both industry and Danish authorities. Read their guidance here (Danish only).
Keep abreast of the latest news and information regarding MDR and make sure your products are ready for the new regulations. SAXOCON can help you to ensure your products are qualified.
Are you ready? We are.
Whether you are manufacturing medical devices, pharmaceuticals or combination products, you will be using materials. Marketing your products in the EU requires that you ensure the quality and safety of the materials used in your products. Early and robust material selection is key to meeting regulatory requirements and mitigating the risk of unexpected events.
In our latest webinar, SAXOCON CTO, Carsten B. Senholt, discusses the importance of materials readiness and its role in the proper selection of robust materials candidates for production.
Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But the things that we manufacture that we come into contact with must be safe. This is true for everything we use or wear but especially so for medical devices.
Any medical device that comes into direct contact with people’s skin, blood or organs; or has indirect contact via contact with food or by conducting air or fluids that interact with people must be CE Certified to be marketed in the EU. Depending on their duration and type of body contact must undergo a physicochemical, morphological, and topographical (PMT) analysis, as defined by ISO 10993-19.
Correctly conducting a PMT analysis requires care and skill and is a critical step in ensuring product safety. Once completed, you will be better prepared to make well-informed decisions about your medical device and its readiness for the market.
SAXOCON has the expertise to help you get your medical devices compliant and certified for sale in the EU.
SAXOCON is pleased to announce that our CTO, Carsten B. Senholt, will present at the 2021 Extratables and Leachables forum.
Carsten will discuss the importance of materials readiness and its role in the proper selection of robust materials candidates for production.
Proper materials selection is key to an intelligent and cost-effective extractables and leachables test strategy.