Faster to Market Approval
We guide you confidently through MDR, IVDR, GMP and
FDA requirements:
reliable, compliant and efficient.
Regulatory Compliance for Medical Devices and Pharmaceutical Products
The certification and regulatory management of medical devices and pharmaceutical products require clear structures, robust documentation, and a thorough understanding of the applicable requirements. The MDR, IVDR, GMP requirements, national regulations, and international registration requirements often interact with one another.
With our Lean Regulatory Compliance approach, we support you in assessing regulatory requirements at an early stage, integrating them efficiently into your development and manufacturing processes, and implementing them in a way that meets auditors’ and authorities’ expectations. This creates clear processes, complete documentation, and a reliable basis for certification, approval, and market access.
We support projects from intended purpose and classification through conformity assessment, technical documentation, gap analysis, audit preparation, and regulatory project management. After products have been placed on the market, we also provide support with vigilance, post-market surveillance, non-conformities, and CAPA measures.
Together with your team, we establish regulatory certainty, reduce unnecessary follow-up questions, and ensure that requirements are not only fulfilled but also translated into practical processes.
Technical Documentation
Structured and audit-ready documentation in accordance with the MDR, IVDR, and GMP. We support you in developing, reviewing, and optimizing your documentation with a focus on traceability, completeness, and regulatory consistency.
EUDAMED & UDI Readiness
Preparation for actor registration, SRN, UDI data, device registration, and regulatory data quality. We help you establish clear data structures, responsibilities, and internal processes at an early stage.
Efficiency and Compliance Assurance
Early classification, clear project structures, and risk-based resource planning make regulatory requirements more predictable, simplify internal decision-making, and improve the management of implementation risks.
Managing Regulatory Requirements Early in Product Development
Regulatory compliance does not begin shortly before submission. Integrating regulatory requirements into development, documentation, and quality management at an early stage reduces correction loops, improves planning certainty, and lays the foundation for efficient certification and successful market access.
Plan for Requirements at an Early Stage
We support development, Regulatory Affairs, and quality management teams in identifying relevant requirements arising from the MDR, IVDR, GMP, and other applicable regulations at an early stage. This results in clear work packages, realistic milestones, and a project process that meaningfully incorporates regulatory considerations from the outset.
Ensure Regulatory Compliance of Customer-Related Processes
Customer-related processes have a direct impact on compliance, customer satisfaction, and market surveillance. We analyse processes relating to complaints, vigilance, post-market surveillance, and reporting and translate regulatory requirements into clear, practical processes within your quality management system.
From Development to Audit-Ready Implementation
We combine regulatory expertise with a pragmatic approach to project management, documentation, and internal processes. As a result, requirements are not only formally fulfilled but translated into structures that reduce the workload for teams and provide targeted preparation for audits, submissions, and assessments.
Targeted Review of Technical Documentation
Before submission to notified bodies or authorities, we review your technical documentation for completeness, traceability, and regulatory consistency. This allows gaps to be identified at an early stage, reduces follow-up questions, and prepares the documentation specifically for the assessment process.
Structured Project Support
Clear responsibilities, defined interfaces, and a risk-based project approach save time and resources. We support your teams throughout the development process, prioritise critical topics, and help implement regulatory requirements efficiently and in a practical manner.
From Initial Concept to Regulatory Approval
We guide medical devices and regulated life science products through every stage of certification in a structured manner. From the initial regulatory assessment and technical documentation to audits, registration, and post-market surveillance, we create clear steps, robust documentation, and greater certainty throughout the project.
Our services: Gap analysis, target market strategy, classification, and conformity assessment planning.
Details: At an early stage, we determine which regulatory requirements apply to your product and target markets. Based on this assessment, we develop a clear strategy for documentation, responsibilities, scheduling, and market access.
Our services: MDR- and IVDR-compliant documentation, clinical evaluation, risk management, and evidence generation.
Details: We support the development, review, and optimisation of technical documentation. The objective is a traceable, complete, and audit-ready structure that takes the requirements of notified bodies and authorities into account.
Our services: Mock audits, audit support, weakness analysis, and preparation for authorities or notified bodies.
Details: We simulate realistic audit situations, identify weaknesses, and prioritise the necessary corrective actions. This allows teams to prepare effectively and ensures that critical issues become visible before the actual audit.
Our services: Submission support, MDR and FDA preparation, EUDAMED readiness, UDI data, and inspection support.
Details: We support the implementation of regulatory requirements relating to approval, registration, and inspections. This includes preparing technical documentation, structuring EUDAMED and UDI data, and targeted preparation for follow-up questions and assessments.
Our services: PMS systems, PMCF, vigilance, complaint processes, reporting, and digital interfaces.
Details: We develop practical PMS and PMCF structures in accordance with the MDR, IVDR, and relevant standards. Particular attention is given to meaningfully connecting market surveillance, customer feedback, and internal quality assurance.
Our services: CAPA processes, non-conformities, process optimisation, customer integration, and continuous improvement.
Details: We analyse root causes, structure corrective measures, and support the sustainable improvement of your processes. The focus is on clear responsibilities, shorter processing times, and effective implementation within the quality management system.
Start your next product approval project with a clear regulatory strategy and a partner who considers documentation, processes, and implementation as an integrated whole.
Contact Us Now
Your Direct Contact
I am happy to assist you personally.