Latest News
FDA Updating Biocompatability Guidance
The FDA is updating their current thinking regarding the type of biocompatibility information needed for certain devices made from common polymers and fabrics that are in contact with intact skin. Read more about the new FDA Guidance here.
SAXOCON can help you pick the right materials that will allow you to waive testing of certain medical device materials.
Find out how SAXOCON can help you here.
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
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.
Does Your Material Classify as a Nanomaterial?
SAXOCON can test and identify nanomaterials based on EC definitions. Let us help you find out if the materials in your portfolio are, or contain, “nano” and to ensure that they meet all relevant regulatory requirements.
Check out our analytical services here.
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.
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
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
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
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.
Alle fagligheder skal i spil, når vi skaber succesfuld innovation
Check out the interview with CEO Martin Friis-Mikkelsen describing the organisational structure at SAXOCON and how it differs from the industry norm.
Read the full article here (in Danish)
DTU IP Pitch 2016
SAXOCON was invited to DTU IP Pitch as an example of a “company success story”.
See SAXOCON CEO Martin Friis-Mikkelsen’s presentation here.
SAXOCON i Dynamo – nyhedsmagasin fra DTU
Fra Dynamo 49 | 09 | 16:
Spinout-virksomhed
fra DTU Fødevareinstituttet:
Bedre arbejdsmiljø og medicinsk udstyr
Vi efterspørger i stigende grad produkter med avancerede egenskaber. Det giver industrien udfordringer i forbindelse med udvikling af metoder, arbejdsgange og ingredienser, der også tilgodeser behovet for sikkerhed.
Det mærker rådgivningsvirksomheden Saxocon, der er ekspert i at hjælpe industrien med analyse af kemiske stoffer.
”Vi får henvendelser fra mange forskellige parter i industrien, og databasen er blevet et vigtigt redskab til at understøtte vores ekspertvurderinger,” fortæller Martin Friis-Mikkelsen, direktør i Saxocon.
Det kan være introduktion af nye kemiske stoffer i arbejdsprocessen eller ingredienser i det færdige produkt, der giver anledning til usikkerhed. ”Med en QSAR-analyse kan vi hurtigt give kunderne et godt grundlag for at beslutte, om de skal droppe introduktionen af et kemisk stof, eller om der f.eks. er behov for yderligere tests, inden de går videre. Det sparer ressourcer hos virksomhederne og gør det meget lettere f.eks. at forbedre arbejdsmiljøet eller udvikle sikre produkter,” forklarer Martin Friis-Mikkelsen.
Han ser et stort potentiale i den nye database.
”Bare inden for produktion af medicinsk udstyr er behovet enormt. Hvordan sikrer vi f.eks., at børn på neonatalafdelingerne kommer i kontakt med så få skadelige stoffer som muligt fra slanger og andet apparatur? Her er QSAR et helt fantastisk redskab,” siger Martin Friis-Mikkelsen.