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Regulatory Strategy consulting

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 8f837126-8dee-437e-ae9b-df1e4702dc7f

Service Description

Our clinic-oriented regulatory strategy consulting offers comprehensive, individualized advice and support on specific issues in the medical device field. We assist you with product identification, clarify demarcation questions, and support product classifications as well as the selection and implementation of the conformity assessment procedure. Additionally, we maintain close contact and communication with the Notified Body to effectively meet your requirements. Our service also includes consulting on Quality Management Systems according to ISO 13485 and re-certification. Our experts support you in technical documentation, conduct gap and requirements analyses, and prepare you for inspections. We also offer internal audits to ensure that your systems and processes comply with current regulatory requirements and are continuously improved.

Our consulting topics particularly include clinical evaluation, including advice on clinical strategy and clinical benefits, as well as equivalence assessment. We provide comprehensive advice on the selection of clinical data, determine the type and extent of required data, and recommend suitable data sources and methods of data collection, including Real-World Data (RWD). Furthermore, we support the assessment of evidence levels and classes, as well as ensuring data quality and quantity.

In the area of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF), we offer consulting on the development of PMS and PMCF strategies and support in individual PMS and PMCF activities such as studies and surveys. Additionally, we provide advice on the establishment and implementation of usability engineering and requirement processes to optimize the usability of your medical devices. Keywords: Regulatory Strategy, Consulting, Medical Devices, Intended use, Product Classification, Conformity Assessment Procedure, ISO 13485, Technical Documentation, Gap Analysis, Inspections, Internal Audits, Clinical Evaluation, Clinical Data, Real-World Data (RWD), Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Usability Engineering, Charité - Universitätsmedizin Berlin

Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
Provider Logo

Provider & Contact

Provider Organisation CEED - Charité Healthcare Services GmbH
Provider Country Germany
Published Email ceed@charite.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

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