FSQ Experts

OUR MISSION

In both the automotive and medical device industries, there is an ever-faster pace of technological change, geared towards a future of systems with more diverse and complex functionalities.

Combining expertise and systematic approaches with passion and responsibility, together with our customers we identify and pursue realistic and efficient ways to achieve quality and functional safety for high-end products, on time and within budget.

FSQ Experts provide many years of experience in this art and are deployed globally.

OUR COMPETENCES

AUTOMOTIVE

Increasing safety and efficiency by training:

We offer a combination of e-Learning, Blended Learning and customer-specific In-house Workshops to achieve high learning- and cost-efficiency.

Consulting Top-Level Management

… in sensitive matters of organisation and development processes, also regarding speed and cost efficiency, if a company-wide Safety and Quality Culture in hearts and minds is to be created.

Supporting customers in applying EchoScrum®, an Agile Development Model specifically designed for safety relevant development:

Each feature sprint is invariably followed by the “echo” of a safety sprint. One single team is developing feature and safety incrementally. At each stage, product-increments compliant with the relevant standards of Product Safety are available. Thus, a belated development of safety is prevented.

Empowering customer teams to achieve compliance to Quality and Product Safety Standards

… like Automotive SPICE®, ISO 26262:2018, 2nd ed., ISO/PAS 21448, ISO 21434, UNECE WP.29. Hands-on coaching for the creation of processes and work-products (Requirements, Item Definition, HARA, FSP, FSC, TSC, FMEA, FMEDA, DFA, STPA, TARA, Verification Reviews) by best-practices.

MEDICAL DEVICES

Quality Management

We provide mentoring and assistance through implementation and maintenance of a quality management system for medical devices in line with ISO 13485 requirements.

Systems Engineering

We support our customers throughout product lifecycle development in the areas of requirements management and traceability, verification and validation, reliability and dependability analysis, and usability engineering.

Risk Management

We work with our customers in order to establish and implement comprehensive risk management processes for their products that fulfill the requirements of ISO 14971 and coach them hands-on in applying them.

Regulatory Affairs

We advise on the best regulatory strategy suited to your medical devices for different markets such as Europe, the USA, and China based on the most up to date regulatory requirements.

SUCCESS STORIES