Product Development and Verification Medical

Developing products in the medical environment not only poses special technological challenges, but also has to meet the highest quality assurance requirements. EXCO supports the regulated industries with its comprehensive range of services related to development and quality management.

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

Regulatory advice

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.

Approval process

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.

Product development

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.

Product safety

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).

Design Verification – Hardware

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.

Design Verification – Software

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.




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