Navigating the regulatory industry

Knowing your product’s regulatory testing requirements will help you budget and schedule your product launch




We use standards to provide constant continuity and maintain proven practices throughout the new product design and development process.

Standards simplify communication and promote consistency and uniformity.


Navigating the regulatory industry

Medical devices containing electronics are regulated by 60601-1 – a harmonized standard required for device sales in the United States, the European Union, Great Britain, and several other countries and jurisdictions. Pro Engineer Portal can help your team navigate this regulatory environment and provide up-front trade-offs between product features and required compliance testing. Knowing your product’s regulatory testing requirements will help you budget and schedule your product launch.


Regulatory testing requirements

Medical devices containing electronics are regulated by 60601-1 – a harmonized standard required for device sales in the United States, the European Union, Great Britain, and several other countries and jurisdictions. We can help your team navigate this regulatory environment and provide up-front trade-offs between product features and required compliance testing. Knowing your product’s regulatory testing requirements will help you budget and schedule your product launch.


Risk Management – ISO 14791

Risk Management – ISO 14791 – can be a useful process if done at the right time in your product development. For medical device product development, Risk Management can help your team reveal shortcomings or other risk mitigating features that will enhance your product. We can help your team navigate and use the Risk Management process as part of our collaboration to enhance your product and avoid costly field complaints.


The European CE mark

The European CE mark is required to sell or use physical products in most of Europe. Unfortunately, there is no standard checklist of tests or certifications. Our team at Pro Engineer Portal has experience with CE mark testing in several device categories and we can help you understand the requirements, budget, and schedule necessary for CE mark compliance.


Standards eliminate the need to invent yet another solution to the same problem

We assess compliance of standards as part of a technical review and audit. Usually, regulatory mandates or clients determine these standards. When such standards exist, assurance activity must be established to ensure they are strictly followed. Standards eliminate the need to invent yet another solution to the same problem. We use standards to provide constant continuity and maintain proven practices despite expected individual preferences within organizations.




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