Select Page

Latest News

Safe In Vitro Diagnostics

Safe In Vitro Diagnostics

Do you manufacture an in vitro diagnostic medical device? If so, you will need a CE Mark certificate to market it in the EU. A CE certificate verifies that a product is safe and performs as intended. The regulation, (EU) 2017/746 (IVDR) Annex I, prescribes general safety and performance requirements for the design and verification of an in vitro diagnostic medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements and get your product to market.

Check out how we can help here.


EU MDR Day is Upon Us

EU MDR Day is Upon Us

SAXOCON is ready for the EU MDR, are you?

26 May 2021 is the deadline for the full implementation of the new EU MDR (Medical Device Regulation). This will have far-reaching consequences for all medical device manufacturers that want to sell their products in the European Marketplace.

So, to continue marketing your products in the EU after this date, you will need to ensure that your products comply with these new regulations.

Are you ready? We are.

Check out how we can help get your products into compliance.


Breathing gas Pathways Regulations

Breathing gas Pathways Regulations

In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas pathway of a medical device product intended to provide respiratory care or supply substances via the respiratory tract. SAXOCON can help get your products ready for approval.

Check out how we can help here.


Ready for the New Requirements for Joint Food Enzyme Dossiers?

Ready for the New Requirements for Joint Food Enzyme Dossiers?

EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in planning, testing, and documenting the safety of your food enzymes.

Joint dossiers have led to several challenges and data gaps in submitted documentation, which is the background for EFSA requiring that enzyme applicants now send a company-specific full data package. Additionally, these requirements will also require a full toxicological package conducted in accordance with current regulatory guidelines.

For years it has been possible for food enzyme producers to group their individual food enzymes under one umbrella application, provided that these enzymes have the same catalytic activities, are manufactured substantially by the same process and originate from the same organism. However, due to confidentiality issues, this procedure has led to a lack of specific information on e.g. the production strain and the chemical composition of each food enzyme.

Check out EFSA’s presentation about these changes here. EFSA also has a presentation of their AMFEP meeting here.

SAXOCON can help you quickly prepare for these regulative changes.

Find out how we can help here.


SAXOCON Webinar on ISO 10993-17

SAXOCON Webinar on ISO 10993-17

Today we held our first webinar via YouTube Live. Carsten B. Senholt, our Principal Toxicologist and CTO, discussed the breaking news about the newly released ISO/CD 10993-17. So, get up to speed on the newest requirements regarding conducting a toxicology risk assessment of medical device constituents.

Check out the webinar here.


The 1st Extractables and Leachables Network Meeting

The 1st Extractables and Leachables Network Meeting

SAXOCON A/S is proud to have hosted the first Extractables and Leachables (E&L) network meeting and we are looking forward to participating in this exciting and important network going forward.

The E&L network is conceived to support competence building and knowledge sharing among Danish pharmaceutical companies.


We’ve Moved

We’ve Moved

After a 2019 characterised by rapid growth, SAXOCON has moved to new, bigger offices.

Our new headquarters is now located at:

Bredevej 2D
2830 Virum

Get Diections


SAXOCON is a Gazelle!

SAXOCON is a Gazelle!

2019 has been quite a year for us here at SAXOCON. In July we became SAXOCON A/S and today we can proudly announce that we are a GAZELLE 2019 recipient.

This has only been possible thanks to our loyal customers and our skilled and dedicated SAXOCON employees. We take great pride in delivering high-quality and timely services that make a difference, ensuring that medical and medicinal products produced and sold around the world are biologically safe.

Thanks!


SAXOCON A/S

SAXOCON A/S

Today, 1 July 2019, is a great day to be a SAXOCON’er 🙂

We have reached an important milestone and are so proud to announce our new status as SAXOCON A/S.