MD & IVD compliance

From consulting and strategy development to implementation and support,
our comprehensive services can help your business thrive.

Regulatory Compliance

If you are developing a medical device, you need to comply with the relevant regulations and standards. This can be a complex and time-consuming process, especially if you are entering multiple markets. That’s why you need a reliable partner who can help you navigate the regulatory landscape and ensure your product meets the highest quality and safety requirements. We are a consultancy that specializes in medical device regulatory compliance services.We have a team of experts who can assist you with every aspect of the regulatory process, from planning and strategy, to testing and validation, to documentation and submission. Whether you need CE marking, FDA approval, ISO certification, or any other regulatory clearance, we can help you achieve it faster and more efficiently. Contact us today to find out how we can help you bring your medical device to market with confidence.

Quality Assurance

We are a quality assurance consultancy service for medical devices. We help you ensure that your products meet the highest safety, performance, and compliance standards. Whether you need assistance with regulatory submissions, testing, certification, auditing, or training, we have the expertise and experience to guide you. We work with clients across the globe and the medical device spectrum, from simple devices to complex systems. Contact us today to learn how we can help you achieve your quality goals.

Design Control

We offer a comprehensive design control consultancy service for medical device manufacturers. We help you to comply with the regulatory requirements and standards for medical device design, development, validation, and verification.

We have extensive experience in working with various types of medical devices, such as implantable, surgical, diagnostic and therapeutic devices. We can assist you with the following aspects of design control:

Design planning and documentation
Design input and output specifications
Design review and approval
Design verification and validation
Design transfer and changes
Design history file and traceability matrix
Risk management and usability engineering

Verification and Validation Support

We offer a comprehensive service to help you verify and validate your medical device design according to the relevant standards and regulations. Our experienced consultants can assist you with planning, executing, and documenting the design verification and validation activities throughout the product development lifecycle.

Whether you need to perform usability testing, biocompatibility testing, risk analysis, or clinical evaluation, we have the expertise and resources to support you. Contact us today to learn how we can help you achieve your quality and safety goals.

MD & IVD compliance

Regulatory Compliance

Quality Assurance

Verification and Validation Support

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