Installing a Quality Management System is essential for any medical device company.  You need the system to improve your quality, while maintaining proper compliance with all regulations.  However, you do not want the system to weigh your company down with unnecessary paperwork that will slow innovation.  What sets our team apart, is that while many people install quality systems, we use our quality systems for ourselves and our clients.  So, all advice, work, and processes that are developed by our team will have a solid foundation of real work principles and not just “best practices”.

We have proven procedures and processes that we utilize to form the foundation of your quality system.  We know these procedures work for businesses because we use them ourselves. We also know that our procedures and processes are compliant with today’s regulations because they have been audited and shown to pass both MDSAP and ISO 13485:2016 standards.

In addition, we have our Electronic QMS system (Q Suite) to help you manage an efficient quality system.

Whether it is QMS installation, QMS real time management, a shared service model, QMS software, Quality System Audits or QMS remediation, we have solutions for your needs.

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  • FDA and ISO 13485:2016 QMS Development

    Do you need a quality management system for medical device development? Do you need the system to be simple and cost effective, yet still meet regulatory requirements? We can help you. We provide daily management of quality systems for ourselves, as well as other medical device companies. So, we are experts at developing effective systems that are simple to manage and meet all regulatory requirements.

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  • Process/Product Validations

    Do you dread having to develop a process validation for your systems? Are you not sure where to start or maybe just need some help thinking the validation planning through? Or likely you have zero time, yet know you are missing this key requirement? Whatever the reason, we have experts that can help you get this task off your plate and get the work done and done well.

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  • Do you dread having to validate your new products or processes?

    Are you overwhelmed with where to start or need assistance in validation planning? Whatever the reason or scope, our team of engineers can provide validations for any of your product or process needs.

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  • Audits

    Do you need an internal audit, but are dreading the findings and the work that comes after? Our auditors are ISO certified, and most importantly, have real world experience. Because our “day job” is managing quality and regulatory systems for companies, it gives us a unique view on how to comply with the regulations, without destroying your innovative nature with bureaucracy and paperwork. We can perform FDA and ISO 13485:2016 audits for Gap or internal requirements, supplier audits, MDSAP (Gap Assessment Audits) and we can also provide support during a regulatory audit. We are here to make your systems better.

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  • FDA Submissions (510k, De Novas, PMAs, etc.)

    Do you have a product that needs regulatory approval? Our experts can develop your strategy, lead your product development team, advise and assist with your testing, write the submission, and interact with the regulatory agency at all levels to help provide a streamlined path to product clearance.

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  • Device Classification

    Do you need help understanding the regulatory pathway for your idea or product? Our team of Biomedical Engineers has years of experience classifying and gaining clearances around the world for thousands of devices and products.

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  • Investigational Device Exemptions (IDEs)

    Clinical research studies are often a key first step in a product development and clearance pathway. Let our experts help you with the regulatory plan, the protocol development, pre-IDE meetings with the FDA, IDE submission, follow-up, and completion. We can help at any stage or any step of this process

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  • FDA Registration and Listing

    Not sure if you need to register with the FDA? Not sure how to register? The FDA registration process is difficult to understand and is not clearly defined or easy to do. Lucky for you, we have done plenty. We would be happy to help you determine if your company is required to register and how to finalize your registration. We will register your company with the FDA at no cost.

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  • Medical Device Reporting (MDRs)

    Do you understand the reporting process? Do you need help understanding or executing the review of complaints? We have experts that understand both the engineering side of the product, as well as, the regulatory aspects of the situation. We can provide expert advice, as well as MDR reporting if needed. Do you need to report an issue to an international agency? We can do that too.

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  • 483’s

    Were you just audited by the FDA and now you have a pile of 483 report forms? Do you know what to do? Do you need extra qualified hands to get them addressed? Or do you have questions and need some advice? Our team can address questions about your 483 forms, provide an extra set of qualified hands to help with remediation and can also handle interactions with the FDA.

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  • International Medical Device Submissions

    Wondering what the requirements for marketing your device in Thailand? Or does Canada look like it could be a great next step for your company? We can help you tailor an international regulatory strategy, as well as execute the plan.

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  • European Medical Device Regulations/CE Mark (EuMDR)

    Are you looking to market your device in the European Union? The recent changes in European Union were of a regulatory nature, but also included a significant cultural change in the way the process works. If you are looking towards European expansion, we would be happy to help you navigate that regulatory pathway.

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  • Clinical Evaluation Reports (CERs)

    As part of the new EuMDR changes, clinical evaluation reports have taken on a more prominent role. Do you have Class I products that now need CERs? Do you have products with outdated CERs? Our team is here to assist in writing and updating your CERs.

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