Training Solutions

From design concept to market. We offer Medical Device specific training. We offer a personal approach where we identify each individual's key learning objectives and agree an action plan. We offer free individual follow up consultation post training.

Introduction Course

An overview of the companies in the sector, the standards they expect, typical working environment and work practices. Includes some general detail on ISO 13485, FDA regulations and Good Manufacturing Practice. Suitable for persons joining or potentially interested in joining the medical device sector. An early step in learning the requirements of the sector.

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RA QA Specialist

Enable a key person in your organisation to monitor and manage the finer details of the quality systems and respond to the myriad of regulatory requests from international jurisdictions. Provide them with the cross section of the specialist skills necessary for supporting Quality Systems and Regulatory related projects.

 

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FDA QSRs

A practical review of the United States FDA regulation for medical device manufacturing including how to implement and maintain the standard and how to integrate it into your system together with ISO 13485. The course will include practical tips on how to avoid warning letters and how to prepare for success using the Quality System Inspection Technique (QSIT).

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Corrective and Preventive Action

Over 50% of FDA 483 observations and Warning Letters are related to CAPA deficiencies. Avoid the pitfalls and system inefficiencies by understanding the regulations and integrating them with best practice problem solving techniques.

 

 

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Process Validation

Understand the principles and benefits of validation. Understand the terms and abbreviations. Develop a practical validation strategy that fits your company and product needs. Discuss and benchmark best practice with your peers.

 

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Device Design

Beyond design concept the medical device designer must operate using regulated design systems and documented records. Learn the regulatory requirements for preparing the Design History File as you design your device for US FDA approval, CE marking and "Rest-of-World" regulatory submissions.

 

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Risk Management

Realise the potential benefits of a well thought out strategy on risk. Learn to separate the relatively trivial issues from the vital few to maximise the return from your resources. This course is based on the requirements of ISO 14971:2007 and GHTF guidance. It includes practical sessions using risk management tools such as FMECA and Fault Tree Analysis.

 

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Management Review

Do management know what the FDA and notified bodies expect? Are management seeing the key trends to enable the right decision making? The FDA inspection starts and finishes with Management Responsibility. Know what to expect and how to prepare. Understand the different emphasis that your Notified Body will place on Management Review.

 

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Medical Device Auditor

In one focused course, learn the auditing skills necessary for efficient and practical internal and supplier audits. Purchasing and Supply control is a hot topic with regulators. This course will help you to identify the weaknesses in your supply chain and internal quality systems.

 

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Ready for FDA?

Learn how to evaluate the status of your systems and records quickly. Prepare for successful inspection with strategies for cross functional team involvement and enlisting management support. This programme covers all of the key practical issues to address when an FDA inspection is imminent. Content includes the Quality System Inspection Technique and first hand knowledge on FDA Inspection approaches.

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FDA

A practical review of the United States FDA regulation for medical device manufacturing including how to implement and maintain the standard and how to integrate it into your system together with ISO 13485. The course will include practical tips on how to avoid warning letters and how to prepare for success using the Quality System Inspection Technique (QSIT).

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Contact Details

Incra Med LTD,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Email: info@incramed.com
Phone: 087 2823571