omologic.es

What It Is

Omologic is a CE marking and product compliance consultancy based in Spain. Its page focuses on EU market access services for medical devices and in vitro diagnostic products. It is not a typical SaaS or enterprise software provider; instead, it primarily offers expert consulting, documentation preparation, licensing support, and coordination with third-party organizations to help manufacturers, importers, and distributors meet MDR 2017/745 and IVDR 2017/746 requirements.

Core Capabilities

Its services cover product classification, analysis of applicable regulations, conformity assessment routes, technical documentation / technical files, ISO 14971 risk management files, ISO 13485 quality systems, software validation plans, clinical evaluation coordination, as well as AEMPS manufacturing/import licenses and distributor communication filings. The page also mentions that, when needed, it can coordinate with laboratories, notified bodies, external customs agents, and provide CE marking training courses.

Pricing and Delivery

The website does not disclose packages, standard pricing, project timelines, or service levels. It only provides consultation channels via phone, WhatsApp, email, and contact form, and indicates that a quote can be requested. Before procurement, buyers should clarify the scope, quotation, deliverables, responsibility boundaries, and whether notified body or laboratory fees are included.

Pros and Cons

The main advantage is its strong focus on EU compliance for medical devices, covering key processes such as MDR, IVDR, AEMPS, notified bodies, and product risk classes. It is suitable for companies unfamiliar with European regulations. The downside is the lack of information on SaaS-style capabilities: online workspaces, permission management, APIs, third-party system integrations, and data security certifications are not disclosed. Pricing and delivery standards are also opaque, making direct comparisons difficult.

Best Fit and Access from China

Omologic is better suited for manufacturers or importers planning to sell medical devices, IVD products, medical software, and imported optical/protective products in the EU, especially companies that need support with local Spanish regulatory procedures. Access from China cannot be determined from the available text, and payment methods are not disclosed. Chinese companies may consider it as a candidate EU-based consultant while also comparing TÜV, SGS, Intertek, EU authorized representatives, and domestic compliance firms with MDR/IVDR experience.