MARACA International Regulatory and Clinical Consulting for Medical Devices and In-Vitro Diagnostics

MARACA International provides regulatory and clinical consultation to support Conformité Européene (CE) and US Food and Drug Administration (FDA) applications for medical devices and in-vitro diagnostics (IVD).

Based in Belgium, the company also offers medical, regulatory, and clinical affairs services to help medical device, IVD, and pharmaceutical firms get their medical devices to market quickly and effectively.

Medical and clinical affairs services for medical devices and IVDs

MARACA International offers a range of unique medical affairs and clinical research (CRO) services. These include product design reviews, advice on companion diagnostic products, risk-benefit summaries, clinical evidence development, clinical performance studies, and on-market protocol development.

The firm also helps prepare a variety of documentation as part of a performance evaluation, which includes a statistical analysis plan, a synopsis, risk management reviews, and assessment of clinical evidence with study plans and reports.

MARACA International also reviews and signs health hazard assessments, risk-benefit studies, and clinical evidence development documents, as well as represent clients to international regulatory bodies.

Regulatory affairs services for medical devices and IVDs

Small or medium-sized manufacturers can outsource all or part of their regulatory activities to MARACA International for effective regulatory affairs management for CE and FDA medical device submissions.

The company offers a detailed strategy plan, featuring a literature review, design input, and high-quality evaluation reports. This service provides medical device and IVD developers with the required documents as part of a notified body submission pack.

In addition, the company helps ease communications between the manufacturer and regulatory agency throughout registration and the approval process.

Once approved, MARACA International’s support continues with MDR reporting, on-market surveillance and vigilance.

Quality assurance services for regulatory registration

MARACA International manages quality assurance (QA) activities to help meet the requirements of ISO 13485, US FDA 21CFR 820, and other international regulations.

Whether a client’s quality system still has to be built or needs adjustments, the company provides guidance on what is needed for a quality system in compliance with the applicable regulations and standards.

MARACA International provides a number of QA support services, including product labelling and supplier management, nonconformity process development, auditing, distribution and manufacturing control, risk management, and design control through a technical file document, as well as corrective and preventative actions (CAPA) process development.

The company also assists clinical laboratories with the implementation of a quality system to meet regulations such as ISO 15189:2012 for medical laboratories, CLIA 42 CFR 493 laboratory requirements, or the FDA QSR 21 CFR 820. This service includes a gap analysis audit, team training sessions, one-on-one guidance, document writing, template development, and QA outsourcing.

Risk management for medical devices and IVD

A number of directives and regulations in the US, EU, and China require risk management as part of product development in the product dossier. MARACA International helps clients conduct risk analysis and evaluations to help meet these regulations using a number of tested templates.

In addition, MARACA International helps form a well-structured risk management file that is consistent, transparent, and compliant with the regulatory requirements.

Performance evaluations for medical devices and IVD

MARACA International performs systematic reviews of scientific literature and provides a performance evaluation plan and report.

This helps identify the gaps in clinical evidence and guides the development of a clinical study plan.

When a clinical study is needed, MARACA International helps develop the clinical study plans / protocols, manages data collection, monitors the study, and generates the relevant report.

Medical device and IVD regulation training

MARACA International has established a series of training modules and general consulting on the most recent developments in medical device and IVD regulations, focusing on the impact it could have on your business. This guidance helps clients remain consistent with the constantly changing pharmaceutical sector.

The company offers hands-on training on risk management, clinical evidence, performance evaluation reports, and the composition of technical documentation to facilitate an upcoming conformity assessment.

These training sessions are available as e-learning courses or in classroom-based sessions.

MARACA International’s training is interactive and focuses on practical implementation. The experienced instructors have a thorough understanding of the current industry issues and provide custom practical solutions. Training certificates are issued to classroom training participants.

Available courses include:

• New EU IVR Regulation 2017/746 and MD Regulation 2017/745
• Companion diagnostic devices
• Complementary diagnostic devices
• IVD Directive 98/79/EC
• Medical Device Directive 93/42/EEC
• General data protection regulation (GDPR)
• Quality systems
• ISO13485 conformity
• 21 CFR 820 conformity
• Design control
• Risk management
• Complaints, CAPAs, and non-conformities
• Medical device reporting
• FDA submission: 510-k or PMA
• Medical vigilance and on-market surveillance