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

Coaching on implementation of a QMS according to ISO 13485 for start-ups
Interim Quality Management for start-ups and middle-size companies
Support on preparation of ISO 13485 and/or MDR Audits

Development Lifecycle

Requirements Engineering
Coordination of Verification Activities (e.g.Packaging Validation, EMC Testing,)
Moderation of risk management workshops
Interim Risk Management (ISO 14971) for start-ups and middle-size companies
Reliability Engineering (e.g. MTTF analysis,Moderation of FMEA,…)

Certification and Regulatory Affairs

Assessment of medical device classes on target markets
Planning regulatory strategy for CE Markt, USA and
China
Support for technical documentation for submissions to notified bodies (STED File, PTR)
Review of claims matrices, IFU or marketing brochures
Support for renewal of product registrations

Post Market Surveillance (PMS)

Planning Post-Market Surveillance (PMS) Activities
Defining strategies for field data collection (e.g.supported by IT cloud solutions)
Review of PMS Reports