Meet your customer’s requirements

Qualification Support

Customers from regulated or high performance industries that purchase your Additive Manufacturing machines have to meet certain requirements. AMPOWER advises you as a supplier how to best support your customer. We help you to understand the industry’s requirements and what the customers needs to qualify your system to produce a validated product. The goal is to enable your customer to achieve a fast production ramp-up with your product.

Our services

Support of system suppliers to enable customers

Industry requirements and regulatory framework
Gap analysis and prioritized recommendations
Qualification templates for your products
Material and process specifications
Support of your customer during qualification

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References

What our customers say

“With AMPOWER, we have been able to develop decisive competitive advantages in the market. The team’s independent expertise in regulated industries such as medical and aerospace is unique on the market.”

Matthias Müller
Branch Manager Aerospace, TRUMPF Laser-und Systemtechnik GmbH

Our Approach

We support you to enable your customer

System suppliers deliver machines to numerous industries that each have their own set of specific demands. The customers, especially from regulated industries, expect the machines and their documentation to meet the existing requirements. AMPOWER supports machine suppliers by providing everything necessary, so your customer can quickly qualify their machines and begin with the production ramp-up. Our service includes an assessment of your machine technology, evaluation of the documentation you provide as well as analysis of your procedures in service and maintenance. We challenge you so you can deliver the best customer experience!

Gap Analysis

Assessment of your machine and your documentation to customer requirements and expectations in order to quickly ramp-up production

Development of qualification documents

Support to develop qualification procedures and documents that you can deliver to your customers

Qualification support

Directly support your customer with our expertise and best practice in qualification

Gap Analysis

Set the baseline for a positive customer journey

The initial Gap Analysis has the goal to find deviations of your value proposition with industry specific requirements in mind. The analysis includes your AM machine, but periphery solutions as well as the documentation and service procedures. Additionally, we will provide a training of your personnel with best practices in machine qualification and give an overview on the current regulatory framework in the largest AM industries. The results from the Gap Analysis is a prioritized list of shortcomings, potential improvements and opportunities for competitive advantages.

Request Gap Analysis now

Identify deviations for machine qualification
Analysis of machine, periphery, documents and procedures
Prioritized To-Do list
Introduction into qualification best practices

Development of qualification documents

Enable your customer’s machine qualification

Once a customer begins their journey with you, they expect you as system supplier to take away their work when it comes to qualification of the machine. AMPOWER can provide you with guidance on best practices of machine qualification and prepare a full set of templates that meets the expectation of your customer’s quality management. This enables your customer to quickly overcome this milestone and begin production.

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Develop machine specific qualification requirements
Develop acceptance jobs
Develop IQ/OQ qualification templates
Support with industry-specific PQ
Improve service procedures

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Industry Requirements

Considering your customer’s requirements

We support you and your customer to successfully use Additive Manufacturing technology in a regulated environment. Introduction of AM in a regulated framework requires a holistic approach that includes the production department, but also R&D, purchasing and general management. AMPOWER provides the needed expertise and supports with the implementation of proved cross-industry best practices. Our support ranges from weekly calls to on-site support to achieve machine qualification and production ramp-up as quickly as possible. This includes necessary documents in form of risk assessment, development of specification and qualification packages as well as deviation and mitigation management.

Medical technology

General quality management in medical technology is defined by ISO 13485. The specifications for the quality management of Additive Manufacturing are based on the component specifications and international guidelines such as those of the U.S. FDA.

Aviation

The EN/AS 9100 provides the framework for quality management in aviation. In addition, the OEM specifies requirements for the qualification Additive Manufacturing.

Automotive

The IATF 16949 defines the general framework of quality management in the automotive industry. To date, only few specifications have been published for Additive Manufacturing.

You want an assessment of your AM machine?
Or you want to become best-in-class to pull ahead of the competition?

Dr.-Ing. Maximilian Munsch

Reach out and send a message to our AMPOWER Partner responsible for projects on gap analysis, qualification and best-practices in operational excellence.

Contact

Knowledge

Market and Technology Studies

Meet your customer’s requirements

Qualification Support

Our services

Support of system suppliers to enable customers

References

What our customers say

Our Approach

We support you to enable your customer

Gap Analysis

Set the baseline for a positive customer journey

Development of qualification documents

Enable your customer’s machine qualification

Industry Requirements

Considering your customer’s requirements

Dr.-Ing. Maximilian Munsch

Knowledge

Market and Technology Studies

AMPOWER Services

Tools, Studies, Publications

Company