Chemicals 4 Medical Devices

Services (ISO 13485)

 

  • Common issues during R&D phase & file registration and production
  • Uncontrolled raw materials with no established specs.
  • Compliant material specs. But Uncontrolled suppliers: Large suppliers such as Sigma or Merck
  • Foreign suppliers:
  • Suppliers without QMS:
  • No counter samples/ retain samples
  • No stability data on raw materials
  • Scalability:
  • Uncontrolled transport
  • No monitored storage

 

How we secure your supply chain.. 

  • First or second supplier.
  • Chemicals and other raw materials for your pharmaceutical or medical application.
  • Selected suppliers
  • Guarantee your specifications of your materials
  • Third party analytical analysis
  • Annual audit reports on suppliers

 

Rather contact us personally?

[email protected]
Sjonni, from origin a process engineer with more than 30 years’ experience in marketing and sales in the research, chemical and pharma industry.
[email protected]
Joris, a biomedical engineer specialized in organic chemistry with a strong background in quality and regulatory affairs.

 

 

 

Tailored packaging

Tailored volume or weight

Looking for tailored packaging solutions in the chemical industry? Whether you need specific volume requirements for each packaging unit, we provide flexible, reliable options. Our expertise ensures that your chemicals are packaged efficiently, complying with industry standards. From small to large quantities, we deliver custom packaging solutions that meet your unique volume needs. Optimize your supply chain with our safe, high-quality packaging services designed to protect your products and maintain their integrity. Contact us today to learn how we can help with your specific packaging volume requirements in the chemical industry.

 

Fields in which we can support

Stability studies Extractables & Leachables Retain samples

 

Our change notification program

Ensure compliance and minimize risks with our Change Notification Program. Stay informed about critical updates to products, processes, or regulations affecting your operations. Our program provides timely notifications, helping you adapt quickly and maintain uninterrupted workflows. Partner with us to stay ahead of industry changes and ensure continuous compliance.

A quick peak in our quality management system

 

 Our ISO13485 Certificate  Our Quality and Risk Policy  Standard Questionnaire answers

ISo13485 certificate 4MedChem

ISo13485 certificate 4MedChem ISo13485 certificate 4MedChem

 

 

 

Did you know?

We can supply,

  • +99,7 % pure monomers, biodegradable
  • Identification of unknown impurities
  • Third party testing
  • Biocompatible & biodegradable polymers

Monomers for Biodegrable polymers

Biocompatible & Biodegrable polymers

Interesting to read..

Polyisocyanates monomeric and polymeric degradation products

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