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Medical Device QMS Consulting and SOP Management

MakroCare has extensive experience in helping companies of all sizes in the medical device industry with efficient and time-saving quality work in medical device quality assurance.

We can create processes and quality management systems that ensure the quality of your processes leading to fewer worries when the next audit appears.

We support you with:

  • Bullet Team Quality Manager, QA and PRRC
  • Bullet Long-term support to your QA/RA staff, based on your needs
  • Bullet Create, implement and update QMS
  • Bullet Perform GAP analyzes of your QMS (MDR, ISO 13485, ISO9001, QSR, etc.)
  • Bullet Internal audits, supplier audits and mock inspections
  • Bullet Support at Notified Body audits
  • Bullet Supplier evaluations
  • Bullet Quality objectives and Process evaluations
  • Bullet Post-market Surveillance (PMS)
  • Bullet Interim Quality Professionals

Quality Management Systems

Our team of experienced consultants can help you develop and implement a Quality Management System covering all aspects of design, risk management, manufacturing, supply chain, post-market activities, and more. Your QMS will be tailored to work for your company.


Interim Quality Professionals

Do you lack the resources to handle Quality in-house? Have a special project that you can’t staff with your internal team members? Our interim quality professionals can support your needs in a cost-effective manner, both remote and on-site, for as long as you require.


Post-Market Surveillance

Our PMS service gathers, records, and analyzes relevant data on the quality, performance, and safety of a device throughout its lifecycle, enabling you to continuously update the risk-benefit assessment and quickly initiate any necessary corrective measures.


Leverage 2 decades of our expereince in setting up QMS, managing ISO 13485 and
SOPs. As QA vendor, our seniorconsultants ensure your Compliance.

The First Step

Let's talk about how MakroCare can help you