Toxicology reporting

Time-to-market can be substantially shortened when inserting toxicology-reporting in the early stages of the development-process for a new medical product or device.
With the assistance of our consultants your company is
on top of all the needed steps towards ISO-certification when launching new products.

Toxicology reporting and ISO10993

Putting safety first – for the sake of the customers
At Medicologic we know the long and difficult proces of developing and introducing new medical products to the markets. We see the struggle for small and medium sized companies trying to stay on top of legislation and documentation. We can support the process by providing our highly skilled consultants, with extensive experience – we help you in getting the job done, and the products ready for launch.

Why is it important?

The product has to be safe!
Both the engineered efficiency functions, and the biological composures has to be in line with the ISO10993-guidelines applied by the FDA (USA) and EMEA (Europe) – if the product is to be introduced to various international markets.

The documentation-process

The work starts with analyzing the user perspectives of the product:

– what is the contact-points for the user
– what is the product’s function for the user?
– what needs to be tested in order to produce a safe product for the end-user?

Toxicology is the key to determine whether or not a product is “safe” – and this is why the limit values of the products are essential in the testing-process.
The test-process consists of: 1) biological evaluation plan, 2) biological risk assessment, and 3) biological evaluation report.

The final delivery

The final version of the documentation is set up in Word/PDF documents.
The report is send to the authorities, and is applicable for the products until the chemical combination of the product is changed in the production-process.

Know-how, skills and mindset

 

At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.

Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.

Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.

We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.

The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com