Once your product is on the market, most of your new security vulnerabilities will probably be found in your vendors’ libraries. You will need to set a policy and implement it for how people should send you vulnerability reports when they find one in your product.
ONEKEY’s CRA Readiness Assessment provides a structured review of an organization’s existing development processes, security controls, and documentation. Based on international standards such as IEC 62443‑4‑1 and ISO 19011, the assessment identifies maturity levels, compliance gaps, and concrete next steps.
Regulators on both sides of the Atlantic have made clear that security must be designed in, not bolted on. For those working with connected products destined for the European market, the shift is already here.
However, as connectivity increases across devices, so does the risk of cyber attacks. For engineers tasked with designing these devices, security by design is more imperative than ever for compliance.
By embedding security into the design and validation process, manufacturers can bring safer, more innovative devices to market faster. For engineers, it offers a structured, standards-based approach to solving one of the most complex challenges in modern medical device development.
To support its decision, the Commission cited numerous efforts this year to strengthen cybersecurity measures for communications networks, including the establishment of a Council on National Security to advise the Commission on cybersecurity issues, and the adoption of targeted but flexible rules for communications providers.
Article 3.3 d/e/f of the RED deals with network security, protection of personal data, and prevention of fraud. Article 3.3 d focuses primarily on devices to minimize the quasi-physical threats of compromising a device.