ACHIEVE COMPLIANCE WITH EXPERT SUPPORT
Navigating regulatory compliance in healthcare and medical devices is complicated - but essential. At Decos, we make this process easier with tailored services for U.S. FDA, HIPAA, and EU MDR compliance, ensuring your product is always audit-ready.
Let Decos streamline your compliance journey with comprehensive services delivered for Medical device manufacturers, Healthcare technology companies, Medical device OEMs.
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OUR COMPLIANCE SERVICES
HIPAA Compliance
HIPAA Compliance
Ensure your data meets stringent U.S. privacy and security rules while minimizing disruption.
Secure your data and meet all HIPAA requirements with ease. Our HIPAA compliance services ensure that your organization adheres to stringent privacy and security rules to protect patient data, with minimal disruption to your operations. We implement secure systems designed to keep your healthcare services in line with U.S. regulations.
DHF Remediation
DHF Remediation
Fill gaps in your Design History Files to speed up time-to-market and reduce compliance risks.
Design History Files (DHF) play a pivotal role in compliance, particularly under FDA regulations. Our remediation services identify gaps and ensure your DHF is fully compliant and ready for audits. This helps you accelerate time to market while minimizing compliance risks.
ISO 13485 Audit preparation
ISO 13485 Audit preparation
Internal and external audit preparation to ensure your quality management system meets regulatory standards.
Navigating ISO 13485 requirements is crucial for ensuring your medical device quality management system (QMS) meets international regulatory standards. At Decos, we offer comprehensive support to help you establish, maintain, and audit your QMS for full ISO 13485 compliance, from documentation to audit preparation.
SaMD Compliance
SaMD Compliance
Navigate FDA and EU MDR pathways for Software as a Medical Device, from risk management to clinical validation.
Software as a Medical Device (SaMD) requires unique regulatory pathways, and Decos is your partner in navigating these. We provide strategic guidance and technical support through the entire SaMD lifecycle, ensuring full compliance with FDA and EU MDR submission processes. Whether it’s clinical validation, documentation, or risk management, we help you meet deadlines and avoid costly delays.
End-to-End Compliance
End-to-End Compliance
Covering post-market surveillance, reporting, and quality management.
Beyond DHF and SaMD, Decos offers a suite of compliance services, including post-market surveillance, reporting, and quality management systems. We help you manage the entire compliance lifecycle, keeping you ahead of changing regulations.
Expertise that drive results!
At Decos, our healthcare and medical device expertise ensure your compliance efforts are handled by professionals who understand the intricacies of regulatory pathways. Our experience spans both large enterprises and SMEs, delivering tailored solutions that align with your business goals and budget.
Why Decos?
- Expert Knowledge: Decos combines deep regulatory knowledge with technical expertise, ensuring every aspect of your product’s compliance is handled efficiently.
- Cost-Effective Solutions: We provide compliance services that help you avoid costly penalties while staying within budget.
- Proven Track Record: Our clients trust us to deliver results that fast-track their market access and maintain long-term regulatory compliance.
Along with helping healthcare companies with technology support, at Decos, we provide innovative digital and engineering services across multiple domains. With a robust engineering foundation, we develop tailored solutions that address complex challenges and drive efficiency.
Partner with us to harness technology that fuels growth and innovation across your entire organization.
Get a tailored compliance plan.
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Suzanne van Tuijl - Mulder
COO Decos Global
+31621465570
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Ensure your product’s success with Decos.
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Devesh Agarwal
Director Decos External Services
INSIGHTS
Blog: How to Create a Patient Implant Card Under the EU Medical Device Regulation (MDR 2017/745)
Blog: How to Create a Patient Implant Card Under the EU Medical Device Regulation (MDR 2017/745)
