Regulatory Affairs in MedTech focuses on ensuring compliance with regulatory requirements for medical devices. These requirements define how a product must be developed, placed on the market, modified, and maintained throughout its lifecycle. They cover regulatory, technical, and clinical aspects of a product across its entire lifecycle.
For manufacturers, this means that regulatory considerations must be addressed early and managed systematically. Errors or uncertainties often lead to delays in development projects, additional requests from regulatory authorities, or restrictions on market access.
What is meant by Regulatory Affairs
Regulatory Affairs (RA) refers to the discipline responsible for managing all legally and regulatory relevant requirements related to the approval, monitoring, and compliance of products. In the field of MedTech, this includes, for example, the European Medical Device Regulation (MDR), harmonised standards, guidance documents, and national requirements.
In practice, Regulatory Affairs in MedTech includes activities such as product classification, the definition of regulatory strategies, and communication with notified bodies and authorities. Regulatory Affairs is therefore closely linked to development, quality management, market access, post-market surveillance, and regulatory intelligence.
Typical challenges in Regulatory Affairs
Many companies face the challenge of correctly interpreting regulatory requirements and integrating them into existing processes. Changes in the regulatory framework require existing documentation and strategies to be reviewed and adapted accordingly.
Common issues include unclear product classifications, inconsistent interpretations of requirements, incomplete technical documentation, and a lack of internal resources with sufficient regulatory expertise. In addition, interactions with notified bodies and regulatory authorities are often time-consuming and difficult to plan.
Our objectives
We provide clarity on which regulatory requirements actually apply to a product and how they can be implemented correctly.
A key objective is to identify regulatory risks at an early stage and assess them in a transparent and structured manner. This helps to avoid incorrect decisions and reduce unnecessary rework.
In addition, we structure regulatory activities in a way that allows them to be integrated into development and project plans. Regulatory Affairs becomes predictable and serves as an integral part of project management, rather than a reactive corrective measure.
We work with
We work with medical device manufacturers, importers, and distributors who need to implement regulatory requirements in a technically sound and efficient manner.
Our primary points of contact within these organisations are professionals responsible for Regulatory Affairs, quality management, development, as well as members of executive management.
Our support is suitable both for companies without an in-house Regulatory Affairs function and for organisations with existing structures seeking additional expertise or further development.
Our services include
Our Regulatory Affairs services include the analysis of the current regulatory situation, the definition of appropriate regulatory strategies, and support in product classification.
We support companies in clinical evaluation and in the preparation of conformity assessment procedures. This also includes the content-related and formal coordination with notified bodies and regulatory authorities.
Our services can be provided on a project-specific basis or throughout the entire product lifecycle.
Strategy and regulatory planning
- Development of regulatory strategies
- Analysis of the impact of regulatory changes on your organisation
- Definition of appropriate standards subscriptions
Development and preparation for regulatory approval
- Preparation or review of regulatory submission documents
- Implementation of regulatory requirements within your quality management system (QMS)
- Preparation of information for updating your technical documentation
- Introduction and implementation of UDI
Approval and market access
- Approval of medical devices (EU, USA, Canada, China, and other markets)
- Registration of your company and products
- Coordination with authorised representatives, notified bodies, authorities, and third-party providers
- Management of your EUDAMED data as Local Actor Administrator (LAA)
- Monitoring of registration certificates
Post-market surveillance and vigilance
- Implementation of post-market surveillance and vigilance processes
- Preparation of PMS plans
- Monitoring of your products on the market (complaints, authority reports, literature)
- Reporting of serious incidents to authorities
- Support in field safety corrective actions
- Preparation of safety reports (PSUR)
- Preparation of internal reports for executive management
Ongoing regulatory compliance
- Monitoring of changes in laws, standards, and guidance documents
- Periodic updates and targeted internal trainings on:
- Standards
- EU regulations, directives, and guidance documents (e.g. MDR, MDCG)
- Country-specific legislation (e.g. MPG, FDA laws)
In delivering our services, we apply the following regulatory and normative requirements relevant to MedTech:
- Medical Device Regulation (EU) 2017/745 (MDR)
- Regulatory requirements for medical devices in CH, EU, USA und UK
- Swiss Medical Device Ordinance MepV 812.213
- ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
