Automation

• Denso robot programing in WinCabsIII /updating and evaluating solutions.
• PLC programming and Code review in Siemens S7 or RS Logix5000.
• Servo systems like Compax 3, Bosch Rexroth Cs, Eurotherm Easyrider and more.

cGMP

• We work every day with “current Good Manufacturing Practices” ensuring the quality of device products.
• We can advise you on Compliance; are you on track and/or ready for the coming challenges?
• We help you prevent product defects by controlling the manner of production.

Commissioning

• Commissioning is the art of “Do it right first time”. We help you make sure your equipment lives up to requirement before use and save a lot of time and problems.
• We can assist you in “Verification of requirements” for your equipment.
• We work according to GAMP-5

Device Test and Trouble Shooting

• We have hands-on experience in function testing according to device specification.
• We understand failures and causes and can assist you achieving a more robust design.
• We are experienced in “Design for testability” giving you a smooth testing process.

Hoisting

• Implementing large equipment often requires “Building modification management” to control the many unknowns.
• We make sure your installation of machinery will be successful.
• Based on our experience we perform RISK analysis and mitigation to avoid surprises.

In-Depth Knowledge of Suppliers

• We have many years of experience and cooperation with key suppliers.
• The right supplier is key to any project; we can help you perform an objective evaluation based on skills, requirement match, price, delivery time, availability, etc., so you select the right supplier.
• We have up to date knowledge of strong/weak sides of each supplier, guiding you to the best possible selection.

Labelling

• We have years of experience with labelling processes and machinery, helping you avoid surprises.
• We can give you expert advice on labels and materials for a successful process.
• We can give you expert advice on compliance within this field.

Machine Construction

• We have expert knowledge in construction and design for the best possible advice on machine construction.
• We are up to date with current construction principles.
• We can advise you on all materials and processes within this field and minimize your project surprises.

Ad-hoc regulatory support for small companies

Quality Management System

Equipment Qualification & Validation

Education & Training Programs

Supplier Management

Machine Trouble Shooting

• We have expert knowledge in machine design and interaction, helping you achieve the best possible process.
• We have experience with “8M” trouble shooting: Man – Machine – Method – Mother Nature (environment) – Material – Measurement – Maintenance – Management: causes and effects within these factors.

Project Management

• We have hands-on experience with initiating, planning, executing, controlling and closing projects with respect to timeline and costs.
• Our experience has taught us how important good stakeholder management is to any project.
• We are communicative and have a proactive behaviour.

Ramp Up OEE Optimization

• We can improve your uptime.
• We can increase your quality.
• We can lift your speed.

Revamping

• We are experienced in improving by changing or re-arrange a process.
• We can help you increase overall plant capacity.
• We can assist you in modifying existing manufacturing processes.

Serialization

• We can advise you within serialization strategy and compliance.
• Expert advice on manufacturing, IT and business processes for your complete overview.
• We have hands-on experience with the current technology within this field.

SOP

• We have years of experience writing Standard Operating Procedures: Standard Operating Procedures.
• We follow GMP: Good Manufacturing Practice.
• We can help you get the right barriers in your process using the right SOP content.

Test Machines

• We can assist you in Device Verification Testing: does function live up to specification?
• We have hands-on experience with Injection Pen testing.
• We have hands-on experience in current Leak testing methods.

Validation

• We can assist you in confirming that a product or service meets the needs of its users.
• We have years of hands-on experience validating machine functions vs URS requirements.
• We can help you creating overview in a RTM: Requirement Traceability Matrix.

Vision Inspection

• We possess design, implementation and verification hands-on experience.
• We have worked with many different applications.
• Vision is a strong barrier in device manufacturing, but has both strong and weak sides; we know which, for your benefit.

Authority Legislation

Design History File

Statistical disciplines

Biological & Clinical Evaluation

Desktop Audit and Gap Analysis

IVD Equipment