Product Development and Verification Medical
Development Products Medical
As specialists in component development for medical devices, we are certified in accordance with ISO DIN EN 13485. EXCO-developed products and electronic components for medical devices meet the highest requirements when it comes to quality assurance and usability.
Verification Products Medical
We ensure that the hardware and software in products that are used in the regulated industries conform to the specific properties. Using verification procedures, we provide documented evidence that the test specimen possesses the specified properties – regardless of use, purpose and benefits
Service portfolio for development and verification of medical devices
EXCO provides advice on all issues of quality assurance, conducts GAP analyses and prepares for audits. We can provide manufacturers with support in risk management and ensure your technical documentation is flawless in accordance with the applicable standards and guidelines.
From the initial idea to approval, EXCO accompanies manufacturers in regulated industries: consultation, workshops, GAP analysis, audits, risk management, technical documentation
CE medical device
We are familiar with the complex requirements of product development in medical technology and are certified in accordance with ISO DIN EN 13485. EXCO supports companies – from start-ups to global players – in dealing with complex transfer processes.
Our aim is to use our knowledge in the fields of regulatory compliance, quality assurance, development, logistics and production to support medium-sized and smaller companies, in particular, with obtaining market approval for their medical or diagnostic products according to MDR and IVDR.
CE machines
We are familiar with the relevant EU directives, regulations and standards that are applicable to your products.
We create conformity assessment procedures and carry out risk assessments in accordance with the current legal requirements.
We compile technical documentation and create rating plates with CE markings.
As specialists in component development for medical devices, we are certified in accordance with ISO DIN EN 13485. The products and electronic components for medical devices developed by EXCO meet the highest requirements when it comes to quality assurance and usability.
EXCO accompanies manufacturers in regulated industries – from the initial idea to approval:
Cyber security
EXCO makes your systems, applications and data stronger with a coordinated mix of technical and organizational security measures.
We ensure compliance according to MDR/IVDR, IEC 62304 and ISO DIN EN 13485 by carrying out tests and providing corresponding technical documentation:
- Threat analysis
- Requirements analysis
- Penetration test
- Vulnerability analysis
Usability
We are specialists in the field of usability tests for medical devices. We ensure that your medical products meet the tough regulatory requirements of the FDA and international standards (IEC 62366).
Hardware testing:
Carrying out mechanical tests, environmental tests, tests for electromagnetic compatibility/EMC, technical documentation in conformity with the IEC 60601 series of standards for medical technology products.
Software testing:
Manual and automated testing, consulting and project management, implementation of documents and source code reviews, risk management and change management, requirements management, implementation of unit, module and integration tests, interface tests, creation of scripts in programming languages such as VB, C, C ++, C#, Java, etc., experts for operating systems such as Windows, IOS, Linux, Unix, Android, etc., software tests for mobile apps, embedded systems, medical products/systems and PC-based medical devices.
We ensure your devices meet the requirements of IEC 62304 for software in medical devices.
