The regulatory environment varies from country to country. A comprehensive understanding of regulatory requirements, timelines and associated costs is required to enter the market. A regulatory strategy aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product.

We can help you to develop a global regulatory strategy by:

• Clarifying national regulatory requirements
• Determining product classification or product grouping
• Determining appropriate route of approval
• Estimating timelines and costs
• Describing Post-market requirements
• Negociating with Health Authorities, e.g. pre-submission meetings

Medical devices and IVDs must be CE-marked before they can be placed on the European Market. Unlike in other markets the legal manufacturer is responsible to demonstrate that the medical or in-vitro diagnostic device meets all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable. Depending on the device classification the involvement of a Notified Body or notification of the device with EU Competent Authorities is required.

Our services for CE-marking include:

• Regulatory Opinion, e.g. on borderline products
• Device Classification
• Identification of applicable standards
• Conformity Assessment, verify Essential Requirements
• Technical File or Class III Design Dossiers
• Risk management according to ISO 14971
• Usability according to EN 62366
• Clinical Evaluation
• Labeling, Instructions for Use
• Class I notifications
• Communications with Notified Bodies and Competent Authorities

The FDA review process for medical devices and IVDs is different from the Remarking procedures in Europe. We assisted European based companies to understand the FDA’s way of thinking and compile US regulatory submissions.

Our services for US regulatory submissions include:

• Determination of Device class
• FDA 513(g) submission
• Premarket Notification – 510(k) Submission
• Search for predicate devices, FDA guidance and recognised standard
• Substantial equivalence
• Compilation of 510(k) and submission to FDA
• Premarket Approval – PMA submission
• De Novo submission: alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate
• Investigational Device Exemption – IDE submission
• Preparation for FDA pre-submission meetings
• FDA Establishment Registration and Device Listing
• Facilitation of communication with FDA in the review cycles

We can assist you in writing, publishing and/or reviewing of regulatory submissions in cooperation with your local representative. We have practical experience in regulatory processes in major established and emerging markets and assist you in compiling submissions in different formats, e.g. Summary Technical Documentation (STED) or Common Submission Dossier Template (CSDT).

• Canada: Health Canada (Device License Applications)
• Japan: PMDA
• China: Food and Drug Administration (CFDA)
• Singapore: HSA
• Brazil: ANVISA
• Mexico: COFEPRIS
• On demand other countries, e.g. ASEAN, LATAM, MEA

Healthcare is a dynamic industry and the regulatory affairs profession is crucial to ensure continued success of a company. We assist our clients for a couple of months up to several years either as specialist or executive.
Some typical examples for short-term resource needs are:

• Maternity/paternity leaves
• Ongoing recruitment of growing teams
• Internal re-organization
• Temporary increase of workload

We provide training to your regulatory and non-regulatory staff.

• Regulatory requirements in different countries
• Submission format and requirements
• Individual coaching
• Other topics on request