Consulting and Training

Consulting

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 devil’s advocate as a project progresses.

Leading by Example

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 we’ll also roll up our sleeves and lead your staff by example by working next to them and actually contributing to your project.

It’s this hands-on experience that make the higher levels of our service pyramid so valuable; it’s based on real world experience with current projects.

Our hands-on services include:

• Reviews
• Project Management
• Planning (Quality, Development, Verification & Validation)
• Requirements Development
• Traceability Analysis
• Software Development (Implementation)
• Electronics Design & Development
• V&V Test Design and Procedure Development

Client Challenges

Intertech works with medical device companies to help them meet their most pressing engineering, regulatory, and project management challenges by:

• Complying with regulatory requirements of the FDA and other agencies for device design, development, and validation
• Balancing the interrelated challenges of time-to-market, development cost and product quality
• Launching trouble-free maintenance releases of existing products without impacting new product development schedules
• Validating design, development, production or quality system software

We help our clients overcome these challenges through a combination of high level consulting and training, or by our hands-on engineering services. Some of our clients have used us as a Center of Excellence for specific skills. Other clients outsource turn-key development to us or use us to supplement an in-house engineering team. Many companies come to us to help them get through a crisis related to a delayed or flawed design, or to advise them on a regulatory issue. When the crisis subsides, we work with them to address the weaknesses in their design process that contributed to the initial crisis.

Our goal is to save our clients money while keeping them in regulatory compliance with a robust, cost-effective design, development, and validation process.