Making compliance work in practice
Practical Quality Assurance, Regulatory Affairs and Information Security support for organizations active in or related to medical devices and healthcare.
EHM Compliance helps translate requirements from law and legislation, including MDR, ISO 13485, ISO 9001, ISO 27001 and NEN 7510 into clear documentation, workable processes and compliant execution tailored to your organization.
Recognize these challenges?
Many compliance issues are not caused by lack of intent, but lack of knowledge or challenges caused by several factors, like:
Limited in-house expertise
Regulatory requirements can be complex, while the necessary expertise to correctly interpret law and legislation into your QMS, ISMS or Technical File is not always available internally.
Insufficient capacity
The workload is clear, but the available resources are too limited to meet regulatory deadlines and keep critical documentation, decisions and follow-up activities under control.
Slow or inefficient processes
Procedures and policies exist, but they are difficult to apply in practice, leading to inefficient processes, unnecessary delays, rework and inconsistent execution.
Audit findings and identified improvements remain open too long
Findings or opportunities for improvement are known, but there is not enough time, knowledge or structure to resolve them within the expected timelines.
Friction between QA, RA and other departments
When compliance requirements are not clearly understood across teams, collaboration becomes more difficult, increasing the risk of non-compliance.
Not fully prepared for audits or inspections
All of the above situations may result in entering an audit or inspection without being fully in control, increasing the risk of nonconformities and the additional costs required to resolve them.
“Effective compliance should help your organization move forward. Not slow it down”.
Services built around your compliance needs
Flexible Quality Assurance, Regulatory Affairs, Information Security and general Compliance support for organizations that need senior expertise to serve a need for temporary capacity or a structured project execution.
Project-based compliance support
QMS/ISMS implementation, optimization or digitalisation, process improvement and structured compliance projects with clear scope, priorities and deliverables.
Remediation or preparation
Quick scan of gaps and risks, preparation for audits or inspections, and practical support with findings, CAPAs and compliance backlogs.
Interim QA/RA management
Interim role as QA/RA Manager or senior quality lead, helping set compliance strategy, guide teams, align priorities and keep daily QA/RA responsibilities moving.
Internal auditor or PRRC services
Independent internal auditing, fulfilment of the PRRC role, or targeted training to support regulatory awareness, objective review and audit-ready follow-up.
Emely Middelkoop
Senior QA/RA and information security consultant
With extensive experience in management and leadership roles,
I support healthcare and medical device organizations in quality assurance, regulatory affairs and information security. Over the past 20 years, I have helped organizations translate requirements from complex laws and standards into clear, practical and effective ways of working.
My aim is not only to clarify what needs to be done to work compliant, but also to help people understand why it matters so they can take ownership.
With a pragmatic, structured and hands-on approach, I help organizations move from fragmented or unclear requirements to workable processes, consistent documentation and audit-ready evidence. In doing so, I focus on creating clarity, building buy-in and ensuring that changes can be adopted sustainably by the teams involved.
Access to Notified Body perspective
I work independently, supported by direct access to a trusted specialist network with Notified Body Lead Auditor experience. This provides an additional perspective when complex regulatory or technical interpretation is needed.
Areas of expertise
How may I help you?
