No matter where your company is on its journey, we can help. From full market analysis and concept ideation, to design and development of industry leading solutions.

Our Approach

Over the past 17 years, we have created a team of over 200 with expertise in:

Device Innovation and Connectivity

Device Innovation
and Connectivity


We specialize in next-generation wearable, implantable and in-hospital connected medical devices, software as a medical device (SaMD) and internet of medical things (IoMT).

Data Driven Services and Solutions

Data Driven Services
and Solutions


We enable the capture of real-world data and create insights to improve operational efficiency, increase clinical effectiveness and demonstrate value.

Regulatory Compliance and Security

Regulatory Compliance
and Security


We provide scalable systems based on our regulatory compliant Affinial platform. We can be the legal manufacturer of your connected medical device, system or solution.

Our Solutions in Numbers
20+ Across 20+ Therapy Areas
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Across 20+ Therapy Areas

Endocrinology
Type 2 diabetes
Type 1 diabetes
Gestational diabetes

Immunology
Rheumatoid Arthritis
Crohn’s disease
Psoriasis
Psoriatic Arthritis
Ulcerative Colitis
Systemic Lupus Erythematosus

Oncology
Breast Cancer
Lung Cancer
Prostate Cancer
Non-Hodgkin’s Lymphoma

Respiratory
COPD
Asthma
Sleep Apnoea
Hypoxic Respiratory Failure

Cardiology
Congestive Heart Failure
Stroke
Atrial Fibrillation

Central Nervous System
Multiple Sclerosis

Neurology
Spinal Muscular Atrophy
Epilepsy

Musculoskeletal
Rare Disease – Osteochondrodysplasic

50+ In over 50 countries
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In over 50 countries

Europe
Austria
Belgium
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Poland
Portugal
Slovakia
Spain
Sweden
Switzerland
Turkey
United Kingdom

Americas
Argentina
Canada
Chile
Colombia
Ecuador
Mexico
Peru
United States
Venezuela

APAC
Australia
Hong Kong
Korea
Macau
Malaysia
Taiwan
Thailand
Africa

Morocco
Tunisia
South Africa

Middle East
Egypt
Israel
Kuwait
Lebanon
Qatar
Saudi Arabia
United Arab Emirates

20+ Regulated Medical Devices
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Regulated Medical Devices

Quality Management (ISO 13485, 21 CFR 820)

Information Security for Managed Services (ISO 27001)

Medical Device Risk Management (ISO 14971)

Medical Device Software (ISO 63204)

Medical Device Usability (IEC 62366)

Regulation 2017/745 on Medical Devices (MDR)

Directive 93/42/EEC concerning Medical Devices (MDD)

Medical Device Cybersecurity (UL 2900, TIR 57)

5+ Award-Winning Innovations
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Award-Winning Innovations

European Innovation Partnership on Active & Health Aging
‘Reference Site’
2016

Medical Design Excellence Award
‘Readers’ Choice’
2015

Medical Design Excellence Award
‘Supplier’
2013

Crystal Aware
‘Very Best of Telecare and Telehealth’
2012

Medical Design Excellence Awards
‘Supplier’
2005

Industry Leading Partners

Contact one of our experts to discuss your needs and we’ll find the right solution for you.

Contact Us