Amstermed’s consulting practice supports manufacturers through the full regulatory lifecycle: gap assessment, technical documentation, clinical evaluation, quality management, submission strategy, and post-market surveillance.
We work across MDR, IVDR, UK MDR, Swiss MepV, TGA and US FDA pathways, providing a unified strategy across your international footprint.
The service can be engaged as a standalone project mandate, or bundled with Authorised Representative, UKRP, CH-REP and Sponsor services under a single agreement.
Manufacturers preparing initial market entry to Europe, the UK, Switzerland, Australia or the US.
Legacy device holders transitioning from MDD or IVDD to MDR or IVDR.
Manufacturers preparing for Notified Body technical documentation assessment.
Startups establishing quality systems and regulatory functions from a clean baseline.
Multi-market strategy definition, gap assessment, classification and pathway selection.
Authorship and remediation of technical documentation per MDR Annex II/III, IVDR, UK and TGA requirements.
Clinical Evaluation Plans and Reports (CEP/CER), Performance Evaluation for IVDs, literature methodology and post-market clinical follow-up.
ISO 13485 implementation, remediation, MDSAP preparation, internal audit and management review support.
PMS plans, PSUR, PMCF studies, trend reporting and complaint handling frameworks.
Preparation for and coordination of Notified Body technical documentation assessment and audits.
Cardiovascular devices
Orthopaedic and spinal implants
Software as a Medical Device (SaMD) and AI/ML devices
In-vitro diagnostics
Ophthalmic devices
Dental devices
Aesthetic devices under MDR Annex XVI
Combination and drug-device products
Ten years after the last device covered by the Declaration of Conformity has been placed on the market. For implantable devices, the period is fifteen years.
Amstermed applies the same standard process to every representation and consulting engagement, adapted to the requirements of the specific jurisdiction.
The process is designed to make regulatory obligations legible, auditable, and durable. Each stage produces documentation that becomes part of the permanent mandate record.
Written inquiry received via encrypted email or Threema. Scope and jurisdictions are outlined. A mutual non-disclosure agreement is executed.
Existing regulatory documentation is reviewed: Declaration of Conformity, certificates, quality management evidence, labelling, and technical file summary.
Amstermed regulatory reviewers assess device classification, applicable regulation, and any gaps against the requirements of the target jurisdiction.
A written mandate is drafted defining scope, term, retention obligations, termination and successor provisions, in accordance with the applicable regulation.
The mandate is executed by both parties. Amstermed formally accepts the appointment and coordinates the manufacturer's regulatory particulars.
Notification is made to the competent authority: EUDAMED, MHRA DORS, Swissmedic, TGA ARTG, or FDA registration and listing as applicable.
Regulatory obligations for Medical Device Regulatory Consulting are set out in the primary framework above, complemented by guidance documents issued by the relevant competent authority and applicable delegated or implementing acts.
Legacy devices subject to conditional continued placement, subject to specified conditions.
Legacy devices subject to conditional continued placement, subject to specified conditions.
All devices in scope must comply with the current framework.
Our regulatory consulting services support a broad spectrum of medical devices and in vitro diagnostic products across multiple international markets. Whether you are developing innovative technologies or managing established product portfolios, we provide expert guidance tailored to the regulatory requirements of each device category.
From early product planning and regulatory strategy to technical documentation, submission support, and post-market compliance, our consultants provide practical guidance tailored to your business objectives. We help manufacturers navigate complex international regulations with confidence, ensuring a structured, efficient, and compliant pathway to global market access.