Quality Management

Quality Management at ZP

ZP is an ISO13485 certified company for the manufacturing of biosensors, IVDs and MDs. This means that ZP is able to document and control our clients contract development and manufacturing, within an ISO13485 framework of documents, procedures, requirements and work-orders. 

How can we help

  • Build your QMS based on ISO 13485
  • Guide you towards MDR, IVDR, and FDA compliance
  • Develop your road-map to certification
  • Provide gap assessment
  • Produce plans tailored for your project
  • Create and maintain your technical documentation

Why work with us


We know the amount of headache which is inevitable when building and maintain QMS documentation. We have the knowledge on how to make this journey as simple as possible!

We have hands-on experience in design and development which simplifies the barrier between QMS and engineering.

Step into your QMS journey!

And we will make sure it is simple and effective for you

How we can support you

Our Services



101 Consultancy

Gap Assessment

Standard operating procedures (sop)

Verification and Validation

Document Control

Customised plan for your project

Clinical Evaluation

Post-Market Surveys