Our services

We provide a range of complementary services designed to help entrepreneurs from all business sizes and sectors.
We provide the necessary solutions that help our clients to achieve their objectives, to resolve problems and to improve their efficiency.

ENGINEERING SERVICES

From Concept through completion

We provide a wide variety of innovative and customized Engineering Services.
We address the whole development process: systems, software, electronics, mechanical, quality, and compliance.
We offer design, technical file remediation services to create and update the design information necessary to validate and maintain the device throughout its lifecycle.
We serve the needs of our clients in a timely and cost-effective manner.

Project Management

  • Project Planning
  • Budget & Time Estimation
  • Outsourcing Management
  • Resources Management
  • Project Rescue

Design and Development

  • Electronics & Mechanics Engineering
  • Embedded Software development
  • Integrated Software and Hardware
  • UX/UI
  • Design for manufacture / test / compliance
  • Verification and Validation
  • Prototyping
  • Test Bench design and qualification

Manufacturing

  • Test System
  • Process Validation
  • Design Transfer
  • Equipment Qualification
  • Supplier Selection and Management

Areas of expertise

  • Embedded microcontroller-based systems
  • Analogue sensors and front ends
  • Power supplies
  • Network and communications
  • Low-power and battery-powered design
  • Precision motor drive
  • Optoelectronics and signal processing/filtering
  • IP Strategy
  • Mechnical and Electronical modelling
  • Software test cycle

Quality Assurance & Regulatory Affairs

We provide QMS compliance and Regulatory Affairs solutions that accelerate the success of companies that need to meet regulatory standards. We work directly with you to develop and implement efficient and cost-effective regulatory strategies and submissions; Quality Management Systems implementation, remediation and maintenance

Quality Assurance Services

  • Custom Quality Management System - implementation and maintenance
  • ISO9001, ISO13485, 21 CFR 820, MDSAP, ISO14001
  • Non-Conformity corrections
  • Quality Assurance outsourcing
  • Internal and supplier audits
  • Risk management
  • Clinical evaluation studies
  • Human factors studies

Regulatory Affairs Services

  • Regulatory strategy and pathway
  • Regulatory submission
  • EU Authorized Representative
  • CE Mark
  • FDA Clearance
  • Medical Device Directive 93/42/EEC
  • Medical Device Regulation 2017/745
  • Other European and foreign regulation

Training and Coaching

  • Quality Assurance
  • Regulatory Affairs
  • Good Practices
  • Risk Management
  • Environment Certification

Areas of expertise

  • US, European, Chinese submissions
  • MDSAP, ISO certification
  • IVD devices
  • Medical devices Class I, II, III
  • ETO, irradiation sterilization, packaging validation
  • Process validation (cleaning, welding...)
  • Packaging validation
  • Quality Engineering
  • Quality Control
  • Environment Quality Management

OPERATIONAL EXCELLENCE

We work with our clients, primarily smaller and medium-sized manufacturing and service organizations, hands-on and side-by-side to help them to achieve their business goals by offering practical solutions to  create added value, to eliminate wastes, improve operational efficiency and to improve financial results in the least amount of time.

Our Offer

A comprehensive, pragmatic implementation of Operational Excellence principles with the support of our partner VFM Conseil.

  • Assessment of the organization's current capabilities and opportunities
  • Identification of the spots of great impacts
  • Project deployment
  • Continuous improvement program
  • Operational Excellence workshops

Our Approach

The implementation of simple methods and toolkits by means of:

  • Reducing constraints and process inefficiencies
  • Eliminating unnecesary waste
  • Redusction in process variability
  • Organizational development
  • Creating a culture of Continuous Improvement

Areas of expertise

  • Performance management
  • Cost controlling and financial monitoring
  • Change management
  • Data collection and analysis
  • Process mapping optimization
  • Digitalisation
  • Supply Chain & Logistics optimization
  • Problem solving methods

LET US HELP YOU SUPPORT YOUR BUSINESS GROWTH