Regulatory Affairs

Whether you need technical documentation for CE marking in Europe, documentation and submission of a 510k for registration on the American market or all facets of risk management – with Axxos you have a partner who can support you in all areas of regulatory requirements.

EU MDR, MedDO

The medical device sector has many challenges for manufacturers or suppliers, in Europe under Regulation (EU) 2017/745 (MDR) in the USA or in Switzerland under the MedDO. Our experts at Axxos will help you to successfully maneuver through the requirements with clever registration strategies or find tailor-made solutions for your situation.

Learn more about EU MDR, MedDO
MDR Technical Documentation

With the Medical Device Regulation (EU) 2017/745 (MDR), the basic requirements for medical devices have become stricter. In addition, there are new specifications, structures and required content for the technical documentation. This is true for both, products that have been on the market for a long time (legacy products) or newly developed devices.

Our experts at Axxos provide support for all challenges and bring a wealth of experience from all areas and risk classes of medical devices. Competent advice, MDR-specific documentation review or a clever registration strategy – we provide uncomplicated, pragmatic help exactly where it is needed.

Your contact for this expertise:

Peter Wehrli
p.wehrli@axxos.ch

FDA Services

From 510(k) to FDA inspection support, Axxos has many years of hands-on experience in complying with and implementing FDA medical device requirements.

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FDA Submissions

The regulatory system for medical devices in the USA differs significantly from the one in Europe. Product clearance or approval is granted by the FDA as the central authority. Our experts at Axxos provide support in the following areas:

  • Definition of the best clearance or approval strategy for medical devices (de novo, 510(k), etc.)
  • Interaction with the FDA (pre-submission meetings, additional information requests, etc.)
  • GAP analyses of existing documentation
  • Preparation of 510(k) documentation and support during the submission process
  • Further steps required after approval (establishment registration and listing, US agent, US importer, FDA readiness and mock inspections, FDA inspections or other interactions with the FDA
  • Customized in-house training on all of the above topics
  • And many more

Your contact for this expertise:

Markus Wipf
m.wipf@axxos.ch

Gap analysis and internal status audits

The initial situation must be known at the start of a project. This is the only way to assure an efficient planning and implementation! Axxos supports you with preparatory audits, as-is or gap analyses.

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Development process, V&V

From the product idea for a new medical device through design verification and validation to market release: an efficient development process facilitates the realization of new products and simplifies the path to the necessary documentation for product approval/clearance in Europe or the USA.

Axxos has many years of experience in the development of medical devices. With clever registration strategies and customized processes, we ensure that design inputs, outputs, reviews, verification and validation are always traceable. However, we never lose sight of practicality and feasibility.

Your contact for this expertise:

Markus Wipf
m.wipf@axxos.ch

Risk Management

The need for safety in the healthcare sector is extremely high. Medical devices must comply with the essential safety and performance requirements of Regulation (EU) 2017/745 (MDR). A comprehensive risk management system is required, which must be implemented, applied and maintained. A clear and simple risk management system is the basis for bringing a safe and high-quality product to the market.

The EN ISO 14971 standard, which is harmonized with the MDR, provides assistance in implementing a risk management system. However, as always, the devil is in the detail.
How exactly should the acceptance criteria for residual risks be defined in the risk management plan for a specific product? How can an overview of implementation and effectiveness all control measures be maintained? How can the overall residual risk be declared acceptable in the risk management report?

It is crucial how the risk management process interacts with the processes for post-market surveillance (PMS), product development and the clinical evaluation ((link zu Independent Clinical Evaluation expertise)). Only an integrated solution can ensure that the safety requirements for medical devices are met.

Axxos has a large expertise with the diverse requirements for risk management and implements these individually for each medical device or within the complete organization.

Your contact for this expertise:

Markus Wipf
m.wipf@axxos.ch

Update service standards and regulations

There are many applicable laws, standards and guidance documents in the medical device industry. The Axxos update service monitors and summarizes the changes in a comprehensible annual or semi-annual report.

Learn more about Update service standards and regulations