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Regulatory Services Medical Device & Diagnostics

As a medical device Manufacturer, whatever maybe your business strategy, it needs to be complemented with effective quality, regulatory and clinical strategies for strong successful commercialization. Getting the right strategy is very important in ensuring the best possible outcome for both the patient and the company. Our medical device & diagnostic regulatory experts can facilitate you get a deep understanding of the applicable regulations and requirements, offering the retrospection and advantage needed to give you clear guidance from start to end of the product submission process and life cycle management.


With over 20 years of strong experience, MakroCare’s global team of experienced regulatory professionals with years of industry and health agency/ NB experience can lead as full service partner or complement your teams in areas where you need help.

Some of our Services:

  • Regulatory advisory services for specific needs or transformation/transition projects from gap analysis to remediation.
  • Leverage our Regulatory Intelligence database of 100+ countries regulatory requirements.
  • Designing Regulatory Strategy for effective development and approval of your devices in various countries: US, EU, Asia and others.
  • EU MDR & IVDR Gap analysis & remediation.
  • Build 510(k), Pre-market Approval Application (PMA), TFs (use our software tools for greater efficiency).
  • Advice on HA/NB audits or remediating the findings/observations with our specialists.
  • Regulatory life cycle support: Impact Analysis, Change Control, Applications Preparation and Submissions.

For an initial discussion, please contact us at

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