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Medical Device Regulation Consulting Services, Berlin, Germany

Partner up with a team of specialists with over 10 years of experience in AI/ML based R&D projects for most effective digital health, medtech and sports product development.
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MDR in general

The EU Medical Devices Regulation, adopted in April 2017 and fully applicable from May 2021, aims to enhance patient safety in digital healthcare. On March 7, 2023, the transition period for compliance was extended until December 31, 2028, for pre-May 2021 certifications. Despite the challenges, this regulation helps medical device manufacturers ensure compliance, improve health outcomes, and boost brand credibility and competitiveness.

Read full artice: What eHealth companies should know about MDR

Types of Medical Devices and Medical Software we can help you make MDR compliant

Picture of a doctor showing the patient a scan of the brain on a screen

AI-Driven Diagnostics

  • Medical Imaging Analysis Tools
  • Wearable Health Monitors
  • Cardiovascular Diagnostic Devices
  • Respiratory Diagnostic Tools
  • Dermatology Diagnostic Apps
  • Neurological Diagnostic Tools

Digital Therapeutics

  • Diabetes Management Apps
  • Cognitive Behavioral Therapy (CBT) Apps
  • Mood and Anxiety Trackers
  • Alcohol and Drug Addiction Recovery Programs
  • Post-Surgery Recovery Apps
  • Chronic Pain Management Tools
  • ADHD Management Apps

Remote Patient Care

  • Telemedicine Platforms
  • Remote Monitoring Devices
  • Emergency Response Systems
  • Medication Adherence Tools
  • Home-Based Lab Testing Kits
  • Remote Rehabilitation Tools
  • Sleep Monitoring Devices
A parent's hand can be seen taking a video of a sleeping child on a smartphone to diagnose the condition.

Telemedicine

  • Virtual Consultation Platforms
  • Digital Patient Engagement Solutions
  • Online Booking Apps
  • Telehealth Software with EHR Integration
  • Remote Patient Monitoring Systems
  • Portable Telemedicine Kits
  • Connected Health Kiosks

Punktum is a RAPS Member

Membership of the Regulatory Affairs Professionals Society (RAPS) connects us to the latest regulatory standards and industry practices. This membership ensures that our clients receive expert advice and the latest knowledge for seamless MDR compliance, improving the quality and safety of their medical devices and software.

Punktum already helped to build products for

logo Herzzentrum Munchen
logo Charite
Logo of Berlin Institute of Health

Medical Device Regulation Services

MDR Roadmap for your Medical Device

We offer a comprehensive MDR Roadmap service to take you step by step from your current state to a fully MDR compliant product and guide you through the MDR certification process.

Our engineering team is ISO 13485 and ISO 27001 certified, so the whole process of certifying your device is under one roof, always ensuring that it is MDR compliant. Find out how we can help you:

A. Initial Assessment and Planning

Device Qualification and Classification: We begin by determining if your product qualifies as a medical device under MDR and classify it into the appropriate risk category (Class I, IIa, IIb, or III). Please mind that our expertise and services cover medical devices up to class IIb. This is crucial for establishing the regulatory pathway​​.

Gap Analysis: Our experts conduct a thorough gap analysis of your current documentation and processes against MDR requirements. This includes evaluating your Technical Documentation (TechDoc) and Quality Management System (QMS) to identify any deficiencies​​.

A.1. Device Assessment

Assessment of software regarding the fulfillment of criteria for a medical device software:

  • The assessment of medical device software (MDSW) involves determining whether the software meets the criteria set out in the MDR, in particular those set out in MDCG 2019-11.
  • Key factors include the intended use of the software, its role in a medical environment and whether it performs an action on data that contributes to the diagnosis, prevention, monitoring, treatment or mitigation of disease.

Intended Use of the device or software:

  • The intended use is critical in determining whether the software qualifies as a medical device. This refers to the specific purposes for which the software is intended to be used in a clinical setting.

Operating principle of the device:

  • Understanding the operating principles includes how the device works, its technology and how it interacts with other systems or devices.

MDCG 2019-11 Criteria assessment:

  • MDCG 2019-11 provides guidance on the qualification and classification of software under the MDR. It outlines specific criteria for determining whether software qualifies as a medical device.

A.2. MDR Classification

  • MDR classification is the process of determining the risk class of a medical device, which can be Class I, IIa, IIb, or III. Our expertise and services cover medical devices up to class IIb.
  • Classification affects the level of regulatory scrutiny and the conformity assessment pathway.
  • Criteria for classification include the intended purpose of the device, the duration of use, the degree of invasiveness and the effect on the human body.

A.3. MDR Roadmap

  • Once assessed and classified, we will provide you with a comprehensive MDR roadmap to guide you step by step from your current state to a fully MDR compliant product.

B. Remediation and Development

Action Plan: Based on the gap analysis, we develop a detailed remediation action plan. This plan outlines the necessary steps, assigns responsibilities, and sets realistic timelines to address the identified gaps​​.

QMS and TechDoc Development: We assist in establishing or updating your QMS and TechDoc to ensure they meet MDR standards. This involves creating and revising documents, processes, and records as required by the regulation​.

B.1. QMS Process Setup

eQMS System Setup:

  • Implementing an electronic Quality Management System (eQMS) involves digital tools and software to manage QMS processes efficiently.

Quality Management according to ISO 13485:

  • ISO 13485 sets the standard for QMS in medical devices, focusing on regulatory requirements, risk management, and maintaining effective processes.

QMS TechDoc:

  • Technical Documentation (TechDoc) must be prepared and maintained as part of the QMS, detailing compliance with regulatory requirements.

SOPs (Standard Operating Procedures):

  • SOPs are detailed, written instructions to achieve uniformity in the performance of specific functions. They are critical in maintaining quality and compliance.

B.2. IEC 62304 Compliant Software and Hardware Development Lifecycle Consulting

TechDoc:

  • Technical Documentation under IEC 62304 must include comprehensive details of the software and hardware development lifecycle, ensuring compliance with safety and performance standards.

Human Factors / Usability (IEC 62366-1):

  • IEC 62366-1 focuses on the usability engineering process to ensure medical devices are designed with user needs and limitations in mind, reducing risks associated with use errors.

Data Protection and Security:

  • Ensuring data protection and cybersecurity is crucial in medical device development, adhering to standards and regulations to protect patient information and device functionality.

C. Notified Body Engagement

Selection and Communication: We help you select an appropriate Notified Body and facilitate communication to align expectations and timelines for conformity assessment​.

Submission Preparation: Our team supports you in preparing and submitting the necessary documentation for Notified Body review, ensuring all elements are complete and compliant​.

D. Implementation and Monitoring

QMS Implementation: We guide you through the implementation of the QMS changes, including training your team and integrating new procedures into your operations​.

EUDAMED Registration: We assist with registering your devices in the EUDAMED database, ensuring compliance with all data submission requirements​.

E. Ongoing Support and Training

CAPA and PMS/PMCF: We provide training and support for Corrective and Preventive Actions (CAPA) and Post-Market Surveillance (PMS) activities, including Post-Market Clinical Follow-Up (PMCF) to maintain compliance. Corrective and Preventive Actions (CAPA) are critical components of QMS, aimed at identifying and rectifying issues to prevent recurrence.

Training on CAPA processes involves understanding regulatory requirements, effective root cause analysis, and implementing corrective measures.

Continuous Improvement: Our experts remain available for ongoing consultation and support to help you stay compliant with evolving MDR requirements and industry best practices​.

Meet our consultants

Josua Ziegler

CEO of punktum

10 years of experience in startup and corporate strategy consulting.

Led digital transformation projects across health, finance and sports in Europe and Middle East. 

Marek Tatara, PhD.

10 years of experience in R&D of cutting-edge technologies.

Holds a PhD in automatic control & robotics and leads a team of 20 Deep Tech researchers. Assistant Professor at Gdańsk University of Technology

Krzysztof Radecki

18 years of R&D and technology project leadership experience.

Led tech implementations at Opel, GE Money Bank, CGI, JLL, and Infomotion GmbH.

Tom Sieron

18 years of experience in Service Design, UX and startups.

Founded his first startup in 2006. Managed and mentored 4 startup accelerators, and founded 3 digital agencies. MSc in Biomedical Engineering.

Read what punktum clients have to say

“Punktum perfectly fit into the time frame proposed and also delivered a set of extra functionalities on top of what was agreed before the start. The quality of the code and work including UX/UI was spot on.”

Philipp Reiter

Partner & COO
Eye Square GmbH

“We like how proactive they are when it comes to recommending the best solutions. They also collaborate really well with our in-house team, which is outstanding.”

Jakob Schwankhaus

Co-Founder & CEO
TrueNode

“The collaboration between our internal team and developers from Punktum is exceptionally smooth and efficient. They feel like our extended arm and can adjust their coding practices and conventions to what we have established internally.”

Radoslav Albrecht

Founder & CEO
Bitbond

Punktum is a member of the DAC.Digital Group

Punktum’s digital health product and UX consulting expertise is empowered with DAC.Digital‘s deep-tech delivery capabilities of 120+ engineers and R&D experts working in-house. DAC is headquartered in Gdańsk, Poland and we share a years-long successful collaboration on projects in Germany, EU and beyond.

All of our team members are working from within the EU and in the CET (Berlin/Warsaw) time zone.

Punktum has unique expertise in product design and R&D

We have helped dozens of digital health innovators to build the right product and then build it the right way.


Early-stage startup acceleration experience

We have funded startups ourselves and run four different startup accelerators.

We know how to solve the challenges an early-stage startup founder faces in finding product-market fit and building an MVP.

Deep-tech R&D engineering expertise

At your disposal, a team of 120+ engineers with PhDs in Machine Learning and Data Science have extensive R&D experience in:

  • Artificial Intelligence
  • Computer Vision
  • Embedded Systems and wearables
  • Natural Language Processing
  • Signal Processing

Regulatory affairs and MDR compliance

Our digital health experts are happy to support you with a validated design and development process compliant with:

  • ISO 13485 (Medical Devices)
  • ISO 14971 (Risk Management)
  • IEC 62304 (Software Dev Process)
  • IEC 62366 (Usability)
  • Medical Device Security (TIR57)
  • DSGVO / GDPR and HIPAA
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Start your project fast

Tell us your about your challenge and goals. We will propose the right approach and our team will support you in designing and building your innovative product quickly.
Let’s talk!

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