Med-Di-Dia

MENU menu

Programs to Software, we have a Regulatory Solution for ALL!!

TIME CRITICAL SERVICES

Regs4Tech

 

Are you developing a SaMD/ALaMD?

Looking for Regulatory support?

Look no further!

From Standard Compliance to EU/USFDA Submissions, we shall be your regulatory risk partners!

 

Contact Us!

Internet of Medical Things (IoMT)

 

Do you have many components associated with your Digital Innovation and are not sure of the risk associated with it? 

Do not worry!

Our Experts got you covered. 

Contact us for Complete Risk Management of your IoMT.

 

Contact Us!

Cybersecurity

 

The future of MedTech walks on a double edge sword where Cyber Security poses the highest threat.

Why expose your end-users, digital health innovation to cyber threats? 

Our Experts are here to guard your innovation!

 

Protect us Now!

Regulatory Guardian of your Digital Galaxy!

 

From programs to applications, we will ensure complete regulatory compliance of your digital creations in the Medical world. 

We provide a wide range of services including:

  • Standard Compliance – evidenced-based reviews for Digital Health and Mobile phone apps.

  • Good software practice – Software compliance to the appropriate regulatory standards.
  • SaMD – Software As a Medical Device.

  • AlaMD -AL As a Medical Device.

  • Defining Machine Learning and Artificial Intelligence in the Medical World.
  • Design and Development Practice.
  • Technical Documentation (File) or 510K submission.
  • Managing EU RED Radio Equipment Directive
  • Demonstrating compliance for Electrical and EMC safety Application-Specific advice.
  • Regulatory Guidance for LPBT (Low Power Bluetooth) and wireless communication.
  • Risk management (ISO 14971:2019) for Local connection to the main product and Network connection to another device or server.

  • Cloud Management.
  • Managing and protecting Personal Data and Patient Information on Digital Platforms.
  • Regulatory GAP Analysis report for the EU/USA/UK markets
  • Cybersecurity Risk Management

  • Cybersecurity Threat Analysis.

  • Total Product Life Cycle Report.

  • Management of Digital Supply Chain.

 

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).

LATEST INSIGHTS

Risk Management Analysis (ISO 14971:2019)

Risk Management Analysis (ISO 14971:2019)

Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.

15.7.2022

Patient information management (IFU, Labelling and Cartons)

Patient information management (IFU, Labelling and Cartons)

A ‘Label’ is the identity of the product.

15.7.2022

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

It allows the identification of specific devices on the market and facilitates their traceability.

15.7.2022