Your Partner For Quality and Regulatory Compliance in Medical Device Industry
With 20+ years experience, we are constantly working for better service…
Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for details.
We offer remote in-house training courses to improve staff knowledge, competency and regulatory skills…
On-site and remote audit services are ideal for having a final review of your technical files or QMS before the certification audit.
Medloft helps you ensure that your medical device complies with the applicable standards and regulatory requirements…..
Support you with our experienced team for compliance of your active medical devices which are driven by software or are standalone software
CE Marking MDR Transition
FDA 510(K) Submission
ISO 13485:2016 Quality Management
IVDR EU 2017/746 CE Marking
ISO 14971:2019 Risk Management