Medical Device Services

N&Sz StudyMaster excels in clinical trials, Clinical Evaluation, and Post-Marketing Follow-Up (PMCF) across various stages of medical device innovation. Employing a strategic approach not only secures a competitive edge for manufacturers but also accelerates the market introduction of devices. The Clinical Evaluation stands as a pivotal step for introducing new medical devices to the European market. With N&Sz StudyMaster CRO, you’re assured that your medical device’s Clinical Plan meets all necessary criteria. Our deep understanding of the European Medical Device Regulation and the European In Vitro Diagnostics Regulation guarantees robust support for your regulatory strategies.

Authorized representative

N&Sz Studymaster proudly holds certification under MDR (2017/745) Article 31. (1.) and IVDR (2017/746) Article 28. (1.)

PRRC

With the EUDAMED SRN number HU-AR-000020474, N&Sz StudyMaster maintains a qualified and appointed Person Responsible for Regulatory Compliance (PRRC), aligning with MDR (EU) 2017/745 Article 15 standards.

Responsible for:

the overall planning, direction of regulatory activities regarding the medical devices.
developing and implementing strategies to ensure that the documentation of the medical device is following the effective regulation.
ensuring the compliance of released devices, as well as the post-market surveillance (PMS) and vigilance activities concerning those devices (MDR recital 34, IVDR recital 33)

Clinical Trials

Specializing in a wide array of medical fields including cardiovascular, vascular, orthopedics, urology, and neurology, N&Sz Studymaster CRO champions the development of medical devices through a controlled trial and methodology accepted by notified body. Our acumen extends to both MDR-regulated and locally governed trials, ensuring manufacturers benefit from an adept regulatory strategy.

Clinical trials serve as the cornerstone throughout the development and lifecycle of medical devices.
N&Sz StudyMaster is your ally in:

manufacturers from the clinical strategy development up to clinical study design, and final reporting.
all kinds of trials for Class I – III medical devices, to help collecting high-quality, ISO14155-compliant clinical data.

Start-up and Contracting Management

Our extensive network and seasoned experience with clinical sites enable the swift and apt selection of sites for projects, ensuring expedited and efficient feasibility and site selection. The synergy between our regulatory and clinical teams facilitates the seamless acquisition of essential documents for regulatory and ethics applications and contracting.

Thanks to our contract specialists’ strong site relationships, we swiftly conclude contracts, optimizing project timelines.

Regulatory Submissions

Expertly navigating submissions to Ethics Committees/Competent Authorities, Institutional Review Board (IRB) in compliance with MDR (REG (EU) 2017/745) alongside local requirements, N&Sz StudyMaster adeptly manages communication with regulatory bodies, adapting to the variances across jurisdictions.

N&Sz StudyMaster specializes in:

Preparation and submission of initial trial application to ECs and CAs
Management of questions from ECs and CAs
Management, submission of amendments (substantial and non-substantial)
Submission of SUSARs, Safety Measures, Clinical Study reports and other documents
Communication with Competent Authorities, ethics committees and stakeholders
Regulatory and EC reporting and maintenance
Training in regulations

Clinical Monitoring Services

Ensuring compliance with Good Clinical Practice (GCP) and ISO 14155, our Clinical Research Associates (CRAs) and team members perform clinical monitoring to the highest standards. Our expertise encompasses a comprehensive range of activities, ensuring meticulous oversight of medical trials.

Experience of staff includes but not limited to the following activities:

Feasibility studies
Assisting in Start-up, Contracting and Regulatory procedures (Essential Document Collection&review)
Pre-study Site Evaluation and Investigator Assessments (Site Selection)
Site Initiations / Trainings
Managing subject recruitment
Clinical Monitoring ensuring that the site is always audit ready
Monitoring and Management of from First-in-Man to PMS Flexible, risk-based monitoring
Communication with the sites
Managing protocol deviations
Pharmacovigilance / Safety Management
Site Close-out activities
Filing & Archiving
Quality Assurance, management of Contracted Audits
Translation and translation verification services

Medical Writing Services

Our medical writers, boasting extensive experience in technical, regulatory, scientific, and medical documentation, assist manufacturers in meeting regulatory compliance with high-quality clinical documentation.

clinical investigation plans,
study reports and scientific publications,
newsletters,
training slides,
technical documentation.

Project Management

Our project managers offer unparalleled management of clinical trials, whether locally, across Europe, or globally. Engaged in every facet of the trial, they ensure the collection of critical study data and provide ongoing team training.

Project Management includes:

preparation of study materials – forms, logs, templates, documents
establishment of documentation for regulatory and ethics approval supporting the regulatory team
creation of study plans
training of clinical operation and study site team
organizing Investigator Meetings
regular contacts with the study management/sponsor
supporting CRAs and the sites in CAPA management
overseeing timelines and budget
choosing and managing vendors
creating reports

Clinical Evaluation

A thorough Clinical Evaluation confirms a medical device’s efficacy and safety under intended use conditions, adhering to a strict risk-benefit assessment. Our strategy for Clinical Evaluation outlines the necessity for acquiring new clinical data, and adhering to regulatory standards in the EU, USA, and China.

The N&Sz StudyMaster team rigorously adheres to the evaluation process, ensuring:

a review of existing clinical data
determination of risk/benefit of a medical device
establish the need of additional data
complete the evaluation report
up-date evaluation report if needed (for class III and implantable devices at least annually)