We listen to our clients to determine the appropriate depth of our involvement. Unlike other service providers you may have worked with in the past, Intertech works with clients at four different levels. You decide how much Intertech involvement your situation demands. This is part of what makes Intertech so unique. We can advise, train, and coach you in our areas of expertise, or we can work side-by-side with you to advance your schedule while "leading by example". Our areas of expertise cover electronics and software development, software and product validation, requirements management, project management, product risk management, and regulatory compliance.
Evaluation & Assessment
Our services at this highest level of our services pyramid are valuable for clients who:
- want to assess the state of a project
- need a "gap analysis" for an FDA submission
- need a "friendly audit" to assess how they will do on a real audit or inspection
- need assistance in technical or regulatory due diligence on acquisitions or investments
- want an in-depth project status assessment and detailed recommendations for how we might help at other service levels
Often, clients with significant industry experience only need targeted training on specific topics or areas of expertise.
We provide on-site and off-site training in all our areas of expertise. Training programs can be customized to fit your needs. Training programs run from four hour seminars to multi-day workshops.
We also have collaborated with AAMI to give the AAMI Software Validation class numerous times. Use of AAMI courseware must be coordinated with AAMI in advance.
Training we offer currently includes:
- Developing Compliant Medical Device Software
- Validation of Medical Device Software
- Validation of Production and Quality System Software
- Dealing with GUI Requirements
A consultative or coaching relationship is the level of service that some clients require. A consultative relationship is effective for clients who:
- are working through their first medical device development project
- are attempting to develop or struggling to work with SOPs for device development and validation
- have development, production, or quality employees that are not from the regulated medical device industry who are having difficulty adapting to the regulated environment
- have had regulatory compliance problems in engineering and software in the past and want ongoing help to avoid future problems
We can help you develop an engineering process, periodically review progress to help you stay within the process (or modify the process if appropriate) or we can act as an expert to look over your shoulder on an "as needed" basis. Intertech can act very cost effectively as an advisor, reviewer, or devilís advocate as a project progresses.
This is what makes Intertech so different from most "consulting companies". Not only will we point out deficiencies, train you on how best to address problems, guide you along the way, but weíll also roll up our sleeves and lead your staff by example by working next to them and actually contributing to your project.
Itís this hands-on experience that make the higher levels of our service pyramid so valuable; itís based on real world experience with current projects.
Our hands-on services include:
- Project Management
- Planning (Quality, Development, Verification & Validation)
- Requirements Development
- Traceability Analysis
- Software Development (Implementation)
- Electronics Design & Development V&V Test Design and Procedure Development
- V&V Test Design and Procedure Development