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MEDICAL DEVICE REGULATORY AND COMPLIANCE SERVICES
Meet regulatory requirements. Build compliance into every stage. Keep your product market ready.
COMPLIANCE SERVICES
Decos helps medtech companies and medical device OEMs build compliance into product development. We support design controls, risk management, verification, validation, technical documentation and remediation. As an ISO 13485-certified engineering partner, we combine regulatory expertise with practical engineering support to help you develop products that are ready for audits, submissions and long-term market success.
Our regulatory engineering support includes:
- EU MDR engineering support
- FDA submission engineering support
- Technical documentation preparation
- Software lifecycle documentation (IEC 62304)
- Verification and validation planning
- Regulatory evidence generation
Our quality engineering expertise includes:
- Design controls
- Requirements traceability
- Engineering change management
- Quality documentation
- Audit readiness
- Continuous quality improvement
Our security engineering capabilities include:
- HIPAA-compliant software design
- GDPR considerations
- Authentication and access control
- Encryption strategies
- Audit logging
- Secure healthcare data integration
Our support includes:
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Verification and validation planning
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Requirements traceability
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Technical documentation
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Test protocol development and execution
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Design History File (DHF) support
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Regulatory evidence generation
Our remediation services include:
- Design History File (DHF) remediation
- Device Master Record (DMR) support
- Technical documentation updates
- Traceability improvements
- Legacy product compliance
- Regulatory evidence preparation
WHAT SETS DECOS APART
Unlike traditional regulatory consultants, Decos combines regulatory expertise with multidisciplinary engineering. Our engineers understand both product development and regulatory expectations. Our experience includes supporting:
- FDA 510(k) documentation activities
- EU MDR technical documentation
- IEC 62304 software lifecycle documentation
- ISO 14971 risk management
- ISO 10993 biocompatibility assessment
- UDI and product labelling
- Verification and validation evidence
- DHF and DMR remediation
Documentation gaps delaying your next release?
Let's review your existing documentation and identify where remediation can accelerate regulatory readiness.FAQs
Yes. Decos supports organisations developing products for EU MDR and FDA regulatory pathways by integrating documentation, verification and engineering activities throughout product development. Our teams help align engineering processes with applicable regulatory requirements.
We support organisations implementing and strengthening ISO 13485 quality management processes within product development. Our engineering teams work within ISO 13485-certified processes and help integrate quality activities into software and medical device development.
HIPAA-compliant software development means protecting sensitive healthcare information through secure architecture, controlled access, audit capabilities and appropriate data protection measures. We help integrate these requirements into the software development lifecycle from the earliest design stages.
Design History File remediation involves reviewing and improving existing product documentation to address gaps in traceability, technical records and regulatory evidence. It is commonly required for legacy products, audits or regulatory submissions.
CONNECT WITH OUR DIRECTOR
Every medical device has different regulatory challenges. Let’s discuss yours.