Phillips-Medisize A/S

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Our innovation strength becomes your competitiveness 

within inhalation, injection and connectivity/compliance devices

 

Medicom has over 20 years of experience in servicing the pharmaceutical industry. Our services ranges from supporting our clients in establishing their device strategy through feasibility and development to low volume manufacturing or tech transfer to large scale manufacturers.

We believe that the device industry is changing and a need for innovation power and project execution power is essential for our clients. We see a need from our clients to develop benefit-driven devices to respond to health care reforms; we see a need for developing advanced devices that can overcome challenging formulation issues; we see a need for being able to prepare device projects for future Life Cycle Management initiatives.

Therefore we do not invest in final products, since we believe that device differentiation is key. We invest in technology accelerators and competencies within inhalation, injection and connectivity that give us a head start on device projects by allowing us to use selected technology accelerators to configure client device projects to be executed faster and with lower risk and being able to cope with a wide range of technical challenges. This also means that we are in a position where we can offer the optimal competitive device with exclusive rights to support both market position and reimbursement.

Our services:

  • Strategy & Technology Services: We can guide you through establishing a device strategy for a project or across several therapies using our deep insight in the inhalation and injection market, as well as making road maps for further development. This can also include establishing state of the art mapping and early technology assessments.
  • Feasibility & Concept Services: We can assist you in forming, selecting and qualifying the technologies and concepts that matches your market needs and the high technical demands of your drugs, including fast speed prototypes.
  • Development Services: Our 35+ engineers can take you safely through your development program
  • Clinical & Low volume manufacturing Services: Our low volume facilities can deliver your devices to your clinical trial faster than anybody else under GMP and also in clean room.
  • Legal manufacturer: We can offer to be the legal manufacturer for devices running in low volume needing a CE mark or a 510(k) registration.
  • Tech transfer to large scale manufacturers.

Our competencies:

  • Deep insights in the inhalation and injection device markets.
  • Integrated mechanics, electronics and software development.
  • Connectivity and compliance (e-health).
  • Human Factor Engineering.
  • Project management.

 

Our Quality management system is certified according to:

  • ISO 13485:2003
  • 14001:2004

and compliant to:

  • 21 CFR 820 (FDA audited)
  • Medical Device Directive
  • ISO 14971:2007 (risk management),
  • EN 62366:2008 (usability)
  • EN 60601-1 (electrical safety)