Portal and digital medical technology fair of the largest MedTech cluster in Germany
Risk Management & Regulatory Affairs
Regulations standardise the rules for manufacturers and is the main way to reassure healthcare providers and patients that the devices they are using are trustworthy and will not endanger their safety.
Naturally, certification processes are complex and demanding. We apply our experience with safety-critical applications to help our clients meet industry requirements in a cost-efficient way.
Quality and risk management
A Risk Management Process (following ISO 14971) should be part of any manufacturer’s approach. It will help to identify and analyse project risks, define strategies to mitigate threats, and outline the steps needing to be taken to correct, minimise or avoid their impact.
Managing the different risks right from the start enables a smoother and faster certification process. Critical has considerable experience in supporting clients with the production of all software artefacts and proper documentation for certification, such as:
Regulatory affairs and consulting
For medical devices to enter the market, they need to receive the necessary regulatory approvals. We support our clients in ensuring their compliance with the relevant standards, such as ISO 13485, IEC 60601 series, ISO 14971, IEC 62304 and 21 CFR Subchapter H, among others.
Training
Critical’s training courses are delivered with the professional background of the delegates in mind. The training courses provide attendees clarification on regulatory requirements and scope, presenting a detailed examination of how they can be implemented by manufacturers looking to efficiently deliver safe, effective and secure medical devices which conform to industry best practices.
More information
Verification and validation of software in medical devices / product...
Our experience in a variety of safety-critical areas enables us to deliver an effective and efficient V&V for increasingly complex and competitive medical technology projects. From defining ver...
Checking the health of medical devices
A staggering one in three medical devices have suffered recalls because of failures – with software being the most significant factor. We work to make sure this doesn’t happen, ensuring sa...
Development of Medical Devices - Systems and Software Engineering
Software Development We work in each phase of the medical devices’ development lifecycle and deliver turnkey solutions moving up from requirements definition, through to design, implementatio...
Risk Management & Regulatory Affairs
Risk Management & Regulatory Affairs Regulations standardise the rules for manufacturers and is the main way to reassure healthcare providers and patients that the devices they are using are tr...
Cyber security for medical devices and medical technology companies
Cyber Security The security of embedded devices is a pressing concern for society. Medical devices are no different from other computer systems when it comes to their vulnerability to security b...
Become a digital exhibitor yourself in the online portal of the largest and best-known MedTech cluster region in Germany and inform the world of medical technology about your products and services as well as about news, events and career opportunities.
With an attractive online profile, we will help you to present yourself professionally on our portal as well as on Google and on social media.
