The field of medical-healthcare products not only comprises an extremely broad, but also an extremely demanding product spectrum. For good reason, the international quality standards are at a very high level, which can only be achieved with appropriate controls and regulation mechanisms. Regulatory hurdles therefore have a decisive influence on the success of the companies and increasingly represent an obstacle to innovation and growth. Young companies in particular find it difficult to successfully launch their products on the market with the necessary stamina in view of the fulfillement of regulatory-compliance and reimbursement issues.

Legal requirements are complex and vary from region to region.

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Overview of regional services

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USA

US FDA 510(k)

FDA QSR (21 CFR 820)

US FDA Medical Device Classification

Medical Device Single Audit (MDSAP)

US FDA Official Correspondent

FDA eMDR

Medical Device UDI

Medical Device CFG

QMS Compliance

FDA IVD

Telehealth & Mobile Apps

US FDA Pre-Sub (Q-Sub)

ISO 14971

ISO 13485

US FDA Form 483

QA- & QR Services

US FDA Agent Representation

EUROPE

EU MDR

EU Medical Devices Regulation 2017,745 (MDR)

MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER)

GCP and ISO 14155 Compliance

ISO 13485:2016

Medical Device Vigilance and Incidence Reporting

European CE Marking for In Vitro Diagnostics

QMS Compliance

CE Marking for Medical Devices

Telehealth & Mobile Apps

PMCF

Clinical Trial Data Management

QA & RA Services

European Authorized Representative

iVDR 2017.746

ASIA

PMDA Medical Device Registration

JMDN Consulting

JMDN Code Research

Quality Management System Compliance with Japan Ordinance 169

MDSAP

PMDA Registration for In Vitro Diagnostics (IVD)

Foreign Manufacturer Registration

Telehealth & Mobile Apps

ISO 14971 Risk Management

QMS Audits

ISO 13485 & FDA QSR Audits

QA & RA Services

LATAM

ANVISA Medical Device Registration and Approval in Brasil

Brazil GMP Quality System Compliance (BGMP)

ANVISA Registration Holder Service

MDSAP

Medical Device Vigilance Reporting for ANVISA

Brazil INMETRO Certification

QA & RA Outsourcing

COFEPRIS Medical Device and IVD Registration and Approval in Mexico

Mexico Registration Holder

Medical Device Vigilance Reporting in Mexico

Classification of Medical Devices in Mexico

INVIMA Medical Device Registration and Approval in Colombia

Colombia Legal Representation for Medical Device Companies

GRA offers comprehensive knowledge and many years of experience in the most important markets for medical products worldwide. The expertise of the consulting team enables you to overcome the hurdles of the respective region.

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We take a holistic and integrated view of what is happening in lifesciences today and help your company to manage the future.