FSQ Experts

OUR PURPOSE

OUR COMPETENCES

Systems Engineering for safety relevant products

We have worked with original equipment manufacturers (OEMs), suppliers and
start-ups implementing development processes for safety relevant products at
company level and at project level. With our expertise on product safety, V-Model and
Agile methodologies these organizations achieved a company wide safety culture and
the implementation of development processes compliant with industry standards such
as ISO 26262, ARP4754 and IEC 60601-1

Check out EchoScrum our solution based on ISO26262 + Agile Methodologies

Safety Analysis & Risk Management

We have partnered with several customers to help them implement and perform safety analysis methods. Our expertise, workshop based approaches and customized analysis tools have been proven to be very succesful to accelerate the delivery of complex analyses.

In addition, we manage the risks derived from these analyes thourought the development life cycle and define strategies to monitor the products during their operation life cycle.

Quality Management

Our team of experts work in our customer’s premises as interim Quality Managers providing active hands-on coaching. With this dynamic approach these customers have successfully built and improved their QM system and passed audits without findings.

Certification / Regulatory affairs

We support international companies to reduce the “time to market” of their safety-related products defining regulatory strategies and certification roadmaps. The key to this success is the fruitful collaboration between our customers and FSQ’s legal experts on industry-specific laws, regulations and international technical standards.
We support the deployment of products in: North America, european region and china.

OUR SERVICES

AUTOMOTIVE

Safe Product development

Implementation of development process according to ISO 26262 and ISO/PAS 21448
Implementation of Agile safety oriented solutions such as:
EchoScrum
Coaching, workshops and direct support defining strategies to
establish a solid safety culture.

Field Operation, Monitoring & configuration updates

Planning Field Operation & Monitoring activities
Defining strategies to assess the risk of vehicle functional updates. (E.g: Software updates)
Defining strategies to collect field data

Safety Analysis & Risk management

Creation of Work products according to ISO26262: Item definition,
plans, Safety case, etc.
Creation of Safety analyses HARA, HiRe, FSP, FSC, TSC, FMEA,
FMEDA, DFA, STPA, TARA
Coaching on how to perform safety analyses
Customized tools to automatize safety analyses
Safety management according to ISO26262

Quality management

Implementation of Quality Management process
Performance of gap analyses for compliance with:
- ISO9001:2015
- IATF 16949:2016
- Automotive SPICE® v3.1

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

AEROSPACE

Product development

Implementation of dev. processes:
- Aircraft & System level acc. to ARP 4754A
- SW and HW levels acc. to DO178C, DO 254
Support & coaching on engineering tasks:
- Preparation of plans.
- Requirements Engineering.
- Development Assurance management.
- Configuration Management.

Product safety

Creation of Safety assessments acc to ARP 4761 including:
- Safety Program Plans
- PSSA and SSA
- Safety analyses:
  - FHAs, FTAs, PRAs, CMAs & ZSAs
Risk assessments for specific operation RPAS: SORA

Certification and Airworth. regulations

Support for compliance with
- Aircraft regulations: CS-23, CS-25.
- RPAS regulations: EASA Rules for UAS.
- VTOL special conditions: SC-VTOL-01.
- EASA Part 21

Quality management & Development Assurance

Gap analyses and preparation for audits:
- System Level: ARP 4754A.
- HW and SW Level: DO178C & Do254.
Implementation of QM Systems (ISO 9001, EN 9100).