Who we are ?

We are a MedTech international Compagny & regulatory consulting firm dedicated to helping manufacturers bring safe, compliant, and innovative medical technologies to international markets.
We support manufacturers at every step — from product design and risk management to clinical validation and post-market surveillance.
Simon MedTech Solutions is also a designer, developer, and legal manufacturer of Software as a Medical Device (SaMD)

Our Expertise

We provide end-to-end support across the full lifecycle of medical technologies, backed by over 15 years of international experience in regulatory affairs and digital health.

Regulatory Affairs

15+ years of global experience covering CE, FDA, GCC, LATAM, and African markets, with deep expertise in medical devices and SaMD compliance.

Quality Management Systems

Design, implementation, and maintenance of QMS aligned with ISO 13485, ISO 14971, and global regulatory expectations. SaMD Design, Certification & Distribution — From concept to commercialization: software architecture, regulatory strategy, clinical evaluation, CE marking, FDA pathways, and worldwide deployment

Market Access

Local representation, registration, and distribution support to ensure rapid and compliant entry into new markets.

SaMD Design, Certification & Distribution

From concept to commercialization: software architecture, regulatory strategy, clinical evaluation, CE marking, FDA pathways, and worldwide deployment.

Training & Capacity Building

Tailored programs for manufacturers, distributors, and healthcare professionals on regulatory, quality, and clinical requirements.

Medical & Healtcare Products

Our portfolio covers a wide range of regulated products, enabling seamless market entry, compliance, and sustained growth wherever your business expands

Medical Devices (MD)

All Classes

In Vitro Diagnostic Medical Devices (DMDIV / IVD)

Software as a Medical Device (SaMD)

Cosmetic Products

Telehealth & Remote Monitoring

Food Supplements & Dietary Supplements

Infant Care & Puericulture Products

Connected Health Accessories

Wellness & Home-Care Products

Our Scope

We operate across diverse regions and regulatory ecosystems, supporting global and local actors with a unified, reliable approach.

Africa

Comprehensive support across North Africa, French West Africa, East Africa, and Southern Africa.

Latin America (LATAM)

Tailored strategies for MERCOSUR, Pacific Alliance, SICA, and CARICOM markets.

Global Submissions

Support for EU, FDA, GCC, UK, and Asian health authorities

Who We Collaborate With

Together, we build lasting partnerships that combine technical expertise, regulatory insight, and a shared commitment to improving global healthcare compliance.

Recognition & Client Voices

Together, we build lasting partnerships that combine technical expertise, regulatory insight, and a shared commitment to improving global healthcare compliance.

"Thank you for your leadership in the green submission program. You have been a key leader to ensure our green submission program is effective in the region. Build initially to respond to lockdowns due to the pandemic with your help the program made significant progress reducing time to market and costs as well as tangible environmental benefits eliminating the carbon footprint by reducing travel, mail, and paper. On behalf of the region and the local EMEAC thank you for all you did to support our environmental and efficiency goals".

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VP EMEA-C

MedTech Legal Manufacturer

“Their guidance on FDA registration and quality documentation saved us months of uncertainty. A reliable partner for any company expanding internationally.”

CEO (USA)

Digital Health Start-up

"Simon MedTech Solutions has been instrumental in helping us navigate the MDR transition. Their deep understanding of European regulations and hands-on approach made a complex process remarkably smooth.”

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RA Director Europe

MD Legal Manufacturer

"Simon MedTech Solutions delivered a highly engaging training on post-market surveillance and ISO 13485 implementation. Clear, practical, and tailored to our team’s needs.”

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Quality manager (France)

MD Legal Manufacturer

«You delivered a highly insightful presentation on regulatory pathways in Africa. It was insightful and inspiring. Your expertise and clarity helped us better understand the evolving compliance landscape across the continent. »

RA Director (DUBAI)

Regional Trade Association

« Your involvement and dedication to help resolve Regulatory matters for Maghreb region is really appreciated. Your positive approach & attitude and also great team spirit make you a reliable partner to resolve urgent blockages. Customer Service Team is happy to work with you ! »

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Customer Service Team lead (MEA)

MedTech Legal Manufacturer

"You register our products efficiently across several African markets & Iran, ensuring smooth and timely approvals every time. Thank you"

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Managing Director Africa & IRAN

MedTech Legal Manufacturer

« This is a small note to express my appreciation of your flowless execution, even though this may seem your normal work, but definitely 15 pre-market approvals is higher than the monthly average for Tunisia, you supported that smoothly and flawlessly with a noticeable business acumen and high sense of responsibility and most importantly your positive attitude. »

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General Manager (Africa)

MedTech Legal manufacturer

Thank you for your contribution to finalize the requirements for our internal Regulatory Management System enhancement that will facilitate the ability to update the RA Action estimated timelines (via bulk process). Your contribution with reviewing the process, wireframes, requirements and prioritization matrix was key to have all this work quicker than it usually takes. Thank you for your active participation as well as your contribution.

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RA Director (Global)

MedTech Legal Manufacturer

"Thank you for leading this critical submission in Algeria, despite the challenges faced during submission attempts, you have been proactive, in connecting with the manufacturing site, understanding what is feasible from manufacturing site side, and coming to the meeting with the proposed solution. With that submission, we will be participating in PCH tender."

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Managing Director Africa & IRAN

MedTech Legal Manufacturer