Medical Device & Diagnostics Regulatory Consulting Services
Whatever may be your business strategy is, it needs to be complimented with effective quality, regulatory and medical strategies for a strong successful implementation. Getting the strategy and right people is very important in ensuring the best possible outcome for both the patient and the company.
With over 15 years of strong experience, MakroCare can help you reach those goals by helping you in taking specific tactical tasks or lead the full scope strategy and execution parts in Quality, Clinical and Regulatory areas with innovative and customized solutions. Our global team of experienced professionals with many years of industry and health agency / NB experience, who can customize project plans to meet your requirements. We have built a successful track record of timely and extensive approvals.
MakroCare can help you:
- Offering advisory services for specific needs or transformation/transition projects from gap analysis to remediation
- Designing Strategy for successful and efficient development and approval of your devices in US, Europe & ROW.
- Supporting devices formalizing a strong “Science” foundation to really differentiate in market
- Advice on Regulatory Strategies to meet the requirements of different Regulatory Authorities across the Globe including new EU MDR.
- Advice on HA / NB audits or remediating the findings/observations with our specialists.
Want more information? Get in touch with us