Medical Device

Medical Device Services

Do your company need consultants for medical device services? Our Medical Device services are based on highly qualified consultants with +15 years of experience from many innovative Medical Device projects within the pharmaceutical  and Life Science industry.

Our consultants are ready to help you with a wide selection of medical device services including:

Our services within Medical Device bridge all phases from product development through manufacturing development (e.g. pilot equipment) to validated production.

      • Product development
      • 3D part design
      • Tolerance chain calculation
      • Creative sessions and innovation
      • Design for manufacturing and design control
      • Product risk management
      • HFE – Human factor engineering
      • UE – Usability engineering
      • Design verification and reviews
      • Specification and test of equipment (pilot and full scale),
      • Validation and Documentation (plans, protocols, test plans and reports)

What is a Medical Device? A Medical device is any device/instrument that is intended by the manufacturer to be used, alone or in combination for a medical purpose. Medical devices can help healthcare providers with diagnosis, prevention, monitoring treatment, alleviation or compensation of diseases and/or injuries. Furtheremore, disinfection of medical devices and modification or supporting the anatomy of a physiological process.

Medical devices must be proven to be safe and effective with regulations. A device is required to undergo testing based on the amount of risk posed, before it is allowed to be used.

When hiring Aptio Groups consultants for medical device services and pharma related tasks, we apply our in-depth knowlegde and deep understanding of current and coming regulatory requirements such as:

      • MDD/MDR
      • FDA 21 CFR part 820
      • ISO13485 (Medical Devices – Quality Management systems)
      • ISO14791 (Risk management to Medical Devices)
      • Usability Engineering EN 62366
      • UDI (unique device identification) and normal CE marking.

Design control is the backbone of our services, and we fully understand the importance of a structured and compliant development model. We handle:

      • Medical Devices as well as Combination Products
      • We work both in CAPEX projects with development of new devices and with OPEX projects optimizing existing devices and related production.

If your company need consultants for a medical device or pharma related project, do not hesitate to get in contact with us. Click here to get in contact with us or fill out the form below and we will get back to you.

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About Aptio Group

Aptio Group Denmark ApS is an innovative Danish pharma and engineering consultancy within Life Science. We are dedicated to support and manage projects in all pharma areas in the Life Science Industry. At Aptio group, we provide highly qualified consulting and engineering services within Quality & Compliance, Engineering, Project Management, biotech and Medical Device services to the pharma industry. We employ specialized Life Science consultants working with the largest pharma, biotech and medical device companies in Denmark and EU.

Our office is placed in Hillerod, but our consultants are primarily working at customer facilities in Denmark and EU.

Our office is placed in Hillerod, but our consultants are primarily working at customer facilities in Denmark and EU.