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Quality assurance and regulatory affairs
We are your trusted partner in navigating complex regulations and driving excellence in compliance and quality.
Your partner in quality and regulatory excellence
We provide quality assurance and regulatory affairs (QARA) expertise covering the entire lifecycle of medical devices and in vitro diagnostics (IVDs), from early development to post-market phases globally. Our QARA team has in-depth expertise and understands the challenges of navigating the complex regulatory landscape. Transforming a concept into a market-ready medical device requires a strategic and systematic approach. With a proven track record of successful projects, we are ready to share our insights to support you throughout the development, market launch and post market surveillance of your medical device. Whether you are a startup or an established organization, our expertise spans across various medical devices and device classes. We collaborate closely with you and help you to turn your vision into reality, mitigating risks and optimizing the timelines.
Our services cover:
- Regulatory strategies to adapt changes in the regulatory landscape
- Technical documentation
- Clinical evaluation or IVD performance evaluation
- Biological evaluation
- Market registrations and post market surveillance
- Risk management
- Usability engineering
- Due diligence
- Quality Management System (QMS) services
- Auditing services
- Digital health and cybersecurity
- Outsourcing of Quality Managers and PRRCs to strengthen your team
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.
Quality assurance and regulatory affairs services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices and IVD medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.