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

Creating company-wide safety and quality culture in hearts and minds

We advise management in sensitive matters of organisation and process development. We coach Quality and Functional Safety with the goal to establish both teams as independent competence and control centres top-down.

Increasing safety by team qualification

We combine training-on-the-job, e-learning and customer-specific in-house workshops to achieve high learning- and cost-efficiency. Renowned trainers deliver profound insights and workshops based on many years of experience in industry.

Establishing trust in compliance to ISO26262, ASPICE et al.

We support the creation of processes and work-products (Requirements, Item Deﬁnition, HARA, SPP, FSC, TSC, FMEA, FMEDA, DFA, Reviews, Veriﬁcation Reviews) by best-practices bottom-up.

Enabling system integrator and component manufacturer to cooperate smoothly

We consult system integrators and component manufacturers in achieving a technically grounded and cost-eﬃcient component delivery and supply management according to ISO 26262:2018, 2nd ed., ch. 11.

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.

EchoScrum®

An agile way of meeting the demands of developing safety critical systems!