Accelerate Your Medical Device Journey
Our team of experts is dedicated to guiding your medical device from concept to commercialization. We seamlessly integrate stringent regulatory compliance into every phase of your product development lifecycle.
(ISO 13485, 21 CFR Part 820, ISO 14971, IEC 62366, IEC 60601, ISO 10993, and ISO 62304)
Our Comprehensive Services Include
- Concept and Feasibility Assessment: Validating your idea and defining its potential.
- Design and Development Planning: Creating a robust roadmap for your product.
- Design and Prototyping: Bringing your vision to life through tangible prototypes.
- Preclinical Testing: Evaluating your device's safety and efficacy.
- Regulatory Strategy and Documentation: Navigating complex regulatory landscapes with precision.
- Clinical Trials (if applicable): Gathering critical clinical data to support regulatory approvals.
- Quality Control and Assurance: Ensuring the highest standards of quality throughout the process.
- Post-Market Surveillance: Monitoring your device's performance and addressing any issues.
- Product Life Cycle Management: Supporting your device's long-term success.
PARTNER WITH US TO:
Minimize risks
Our deep understanding of regulatory requirements helps you avoid costly delays and potential recalls.
Accelerate time to market
Our streamlined processes and efficient workflows expedite your product's launch.
Maximize product success
Our focus on quality, safety, and regulatory compliance ensures your device's long-term viability.
Let's bring your medical device to market together
DHF remediation and optimization
We are your partner in ensuring regulatory compliance and product quality. Our comprehensive DHF services are designed to optimize your processes and minimize risks.
Our Expertise:
- In-depth DHF Assessments: We meticulously scrutinize your existing DHF to identify gaps and non-conformities.
- Strategic Remediation: Our expert team develops tailored corrective action plans to bring your DHF into compliance.
- Design Verification and Validation: We rigorously test and validate your product's design to meet stringent regulatory standards.
- Ongoing Compliance: We maintain your DHF's integrity through regular audits and updates.
- Risk Management: We proactively identify and mitigate potential risks to safeguard your product's quality and safety.
By streamlining your DHF, we help you to:
- Accelerate Time to Market: Reduce regulatory delays and expedite product launch.
- Enhance Product Quality: Ensure your product meets the highest quality standards.
- Minimize Compliance Risks: Mitigate potential regulatory penalties and product recalls.
- Optimize Resources: Improve efficiency and reduce costs.
Let's work together to elevate your product development
Navigating the Complex Landscape of Medical Device Regulation
Decos is your trusted partner in ensuring global regulatory compliance for your medical devices. Our experienced team provides a comprehensive suite of services to guide your products from concept to market.
Our Expertise:
- Device Documentation:
- Streamline your product development process with our expert documentation services.
- Ensure regulatory compliance and market access with precise and accurate documentation.
- Labeling:
- Deliver comprehensive labeling solutions tailored to your specific needs.
- From initial concept to final artwork, we guide you through the entire labeling process.
- Regulatory and Technical Writing:
- Our skilled technical writers create clear and concise documentation that meets global regulatory standards.
- We specialize in a wide range of medical device documentation, including STEDs, CERs, PSURs, UOUPs, user manuals, and more.
By leveraging our deep understanding of regulatory requirements and industry best practices, we help you to:
- Accelerate Time to Market: Minimize regulatory delays and expedite product launch.
- Mitigate Compliance Risks: Reduce the risk of regulatory non-compliance and product recalls.
- Enhance Product Quality: Ensure your products meet the highest quality and safety standards.
- Optimize Resources: Streamline your processes and reduce costs.
Partner with Decos to navigate the complexities of medical device regulation with confidence
Medical Device Documentation with Decos
Decos is your trusted partner in medical writing, delivering exceptional services that align with the most stringent regulatory standards. With a deep understanding of global regulations and a commitment to quality, we empower you to achieve your medical writing goals with confidence.
Our Comprehensive Medical Writing Services Include:
- Clinical Evaluation Gap Analysis (CEP & CER): Identify and address critical gaps in your clinical evidence.
- Literature Strategy: Develop a robust literature review strategy to support your regulatory submissions.
- SOP Development: Create clear and concise Standard Operating Procedures to ensure consistent and compliant practices.
- Post-Market Surveillance (PMS): Implement effective PMS plans and generate accurate reports.
- Post-Market Clinical Follow-up (PMCF): Design and execute PMCF plans to monitor product performance.
- Periodic Safety Update Reports (PSUR): Prepare comprehensive PSURs to meet regulatory requirements.
Why Choose Decos:
- Regulatory Expertise: Our team stays updated on the latest regulatory guidelines to ensure compliance.
- Tailored Solutions: We customize our services to meet your specific needs and objectives.
- Rigorous Quality Assurance: We adhere to stringent quality standards to deliver accurate and reliable documentation.
- On-Time Delivery: We prioritize timely delivery without compromising quality.
Partner with Decos to streamline your medical writing process and accelerate your product development
Elevate Your Medical Device Quality with Our Expert QMS Solutions
A robust Quality Management System (QMS) is the cornerstone of medical device excellence. At Decos, we provide comprehensive QMS solutions tailored to your specific needs, ensuring compliance with ISO 13485 and other relevant regulatory standards.
Our QMS Services:
- Strategic QMS Development: We design and implement a QMS that aligns with your business objectives and regulatory requirements.
- Market-Specific Compliance: We identify and address the unique QMS needs of your target markets.
- Comprehensive Documentation: We create essential QMS documentation, including SOPs, work instructions, quality policies, manuals, and design control procedures.
- Regulatory Readiness: We prepare your organization for successful internal, mock, supplier audits, and audits from notified bodies.
- Expert Training: We empower your team with QMS training to ensure compliance and operational excellence.
Partner with Decos to:
- Enhance Product Quality: Deliver safe and effective medical devices.
- Minimize Compliance Risks: Mitigate regulatory penalties and product recalls.
- Optimize Operational Efficiency: Streamline processes and reduce costs.
- Accelerate Time to Market: Expedite product development and launch.
Contact us today to learn how our QMS expertise can elevate your medical device business
Medical Device Safety with Expert Risk Management
Ensure your medical devices meet the highest safety standards with our comprehensive risk management solutions. We are dedicated to helping you navigate the complexities of ISO 14971 and deliver safe, reliable, and compliant products.
Our Services:
- Proactive Risk Identification: We meticulously identify potential hazards and risks throughout your device's lifecycle.
- Design for Safety: We integrate safety principles into your design process to minimize risks from the outset.
- Rigorous Verification and Validation: We validate your device's safety performance through comprehensive testing and analysis.
- Post-Market Vigilance: We monitor your device's performance in the market and take swift action to address any emerging risks.
- Expert Hazard Analysis: We conduct in-depth hazard analyses to pinpoint potential risks and develop effective mitigation strategies.
By partnering with us, you can:
- Enhance Product Safety: Reduce the risk of adverse events and improve patient outcomes.
- Accelerate Time to Market: Streamline your regulatory processes and expedite product launch.
- Minimize Liability Risks: Mitigate potential legal and financial consequences.
- Optimize Resource Allocation: Efficiently manage your risk management efforts.
Let's work together to build a safer future
INDUSTRIES WE SERVE
LIFE SCIENCE | Medical device OEMs | healthcare
WHY CHOOSE US
A Partner That Takes Ownership Beyond Tasks
Expand your potential with our end-to-end mechanical engineering services.
At Decos, we specialize in running entire projects with a focus on delivering exceptional results. We take full ownership, managing projects from initial design through implementation to ensure exceptional outcomes. Partner with us for comprehensive services tailored to meet the demands of your larger initiatives.
35+ Years experience
260+ Curious people
200+ Successful projects
200+ Happy Customers
Global presence
EXPERTISE IN TECH
Our team of engineers excel in crafting software solutions, boasting a proven track record of delivering complex projects.
FLEXIBLE PARTNER
We adapt to changing project requirements, maintain steady progress, and prioritize client satisfaction through active feedback and problem-solving.
USER-CENTRIC
We prioritize user experience, ensuring our solutions simplify processes and effectively meet user needs.
CULTURAL ALIGNMENT
We facilitate seamless collaboration across cultures, time zones, and workflows, ensuring clear communication and effective partnership.
How we work
Discovery
We engage with you to comprehensively identify your challenges, goals, target audience and expectations.
Ideation
We will brainstorm and come up with a solution and implementation strategy that best fits your challenge.
Implementation
We put the ideas into action and develop an MVP and MRP, then we incorporate all the feedback.
Delivery & Support
We deliver the product and stay involved for support, required improvements and any further developments.
Insights
webinar
Understanding Compliance: U.S. FDA and EU MDR
Blog
Critical Role of Medical Device Labelling: Ensuring Safety, Compliance, and Patient Well-being
Success Story
License Renewal of a medical device
LET'S CONNECT
Curiosity is the driving force for positive change. A force without limits. With endless opportunities. When anything is possible, imagine where we can go next!
I am very curious about your challenge, so: let's connect!
