Wearable and implantable medical device development
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Digital health solutions for wearable and implantable medical devices
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Product development for connected, in-hospital equipment
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Digital health solutions for connected, in-hospital devices
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Service capabilities

Needs Analysis


Needs analysis, requirements definition, solution concept creation

Intended use


Definition of intended use and pathway to regulatory submission

firmware design and development


Electronic and firmware design and development

SaMD


Software as a medical device (SaMD) development

E2E integrated device


Software development of end-to-end integrated devices, mobile apps, portals, and cloud-based solutions

operation and management


Operation and management of services and solutions

We have delivered…
20+ Regulated Medical Devices
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Regulated Medical Devices

ISO 13485 Medical Devices – Quality Management

ISO 27001 Information Security Management - for support and delivery of cloud-based systems

ISO 14971 Medical Device Risk Management 

IEC 62304 Medical Device Software 

IEC 62366-1 Medical Device Usability

UL 2900 Software Cybersecurity

Health Insurance Portability and Accountability Act (HIPAA)

General Data Protection Regulation (EU) 2016/679 (GDPR)

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+ 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

Certifications and regulatory compliance
BSI-Assurance-Mark-ISO-13485-KEYB
IEC 62304 Certification
mark-of-trust-certified-ISOIEC-27001-information-security-management-white-logo-En-GB-1019

Our medtech customers