Trusted Quality Management Experts for the Medical Device Industry
Simplifying quality management and regulatory compliance with industry-leading expertise
Comply easily
with
ISO
13485
ISO
14971
QSR
MDR
IVDR
MedQdoc was founded by experts and thought leaders in the Swedish MedTech regulatory space.
MedQdoc was founded by experts and thought leaders in the Swedish MedTech regulatory space. Driven by first-hand experience of complex quality management systems mainly developed for the pharmaceutical or life sciences industry, our founders recognised the need for a more intuitive, user-friendly solution that would simplify regulatory compliance for medical device companies.
MedQdoc’s founders understood that true efficiency requires transparency and collaboration across teams and departments. They envisioned a quality management system that was truly integrated across entire organisations rather than siloed within specialised quality teams.
After evaluating the gaps in existing tools, they created MedQdoc. This specialist medical device quality management software drastically simplifies regulatory compliance and enhances quality management processes.
Innovating Alongside
MedTech Pioneers
MedQdoc is an intuitive quality management software solution equipped with many functions including document handling with electronic signatures, Case management for CAPA, Change Control, Complaint handling and templates for Technical Documentation and QMS procedures.
Created for the medical device industry by quality and regulatory compliance experts, MedQdoc helps companies streamline their compliance journey and ensures efficient collaboration.
Headquartered in Sweden and partnering with clients around the world, our team empowers MedTech innovators to focus on bringing life-changing products to market without being slowed down by the complexities of compliance.
With decades of experience specialising in European and American regulations, our MedQdoc team thoroughly understands and provides tailored solutions for:
- Medical device manufacturers and suppliers of Class I, II and III products
- Companies aiming for compliance with MDR, IVDR, ISO 13485 and 21 CFR Part 820
- Startups preparing for market launch
- Small and mid-sized organisations looking to optimise processes
- Consultants and quality managers who need an easy-to-use and flexible quality management system
Collaborating with Trusted Consultants
As a team of former QA/RA Managers and current QA/RA consultants, we understand the integral role of quality and regulatory advisors in the medical device ecosystem. Many of our customers also have other consultant partners who serve as their QA/RA leads.
We actively collaborate with trusted consultants to equip them with compliance tools that are tailored to their clients’ requirements. Simple and ready-to-use, MedQdoc provides consultants with a streamlined framework to drive compliance and improve quality for their MedTech customers.
The Team Behind MedQdoc
Our team is made up of experts who are not only knowledgeable about regulatory frameworks but also bring a wealth of hands-on experience from within the medical device sector. Their unique experience and know-how position them as one of the few teams in the industry capable of offering full-spectrum support to help companies confidently accelerate their journey to achieving compliance.
Therese Albinsson
As CEO and founder of MedQdoc, Therese provides executive leadership and oversight across all areas of the business. Therese is a member of the Swedish standards committee and serves on the board of Medea, a consortium of leading MedTech QA/RA consulting firms. With her expertise in regulatory strategy, document control, design control and risk management, Therese helps guide clients to implement robust processes that reduce their time-to-market.
Sofie Petersson
With extensive experience in the medical device and pharmaceutical industries, Sofie specialises in management responsibility, resource management, document control, design control, measurement, data analysis and CAPA. As a global QA/RA Director, she has guided companies through numerous successful QSR and FDA audits, as well as Notified Body (NB) audits, ensuring compliance and maintaining high standards. Sofie has also implemented several QMS projects using various digital solutions, enhancing efficiency and regulatory adherence.
As a member of the Swedish standard committee that develops ISO13485 and ISO14971, Sofie has first-hand information on the current interpretation of essential QMS standards, providing our clients with valuable insights into regulatory expectations and project implementation.
Veronica Christmansson
Veronica brings over 25 years of hands-on experience in medical device, pharmaceutical and chemical manufacture, quality assurance and control. Her speciality areas include supplier management, production control, quality assurance and quality control. Having implemented multiple eQMS projects and worked extensively with ISO standards, Veronica ensures MedQdoc’s solutions translate effectively to real-world MedTech environments.
Angelica Winqvist
As a Quality and Regulatory Advisor, Angelica plays a key role in guiding medical device companies to implement robust QMS and technical documentation. With previous experience as QA/RA Manager in the Medtech industry, she excels at creating technical documentation and CAPA and Non-conformity management.
Swedish Medtech Partner and SIS Member
We are regular contributors to Swedish Medtech events and activities, frequently speaking and participating at regulatory summits, breakfast events and other gatherings.
Our memberships at SIS and Swedish Medtech let us stay up-to-date with the latest developments and challenges in the industry, helping us provide better insights to support our clients.
From research and development, to manufacturing and post-market surveillance, our team members have played integral roles in driving quality and compliance strategies for some of the most innovative organisations in the global medical device industry.
Our experienced team understands the common friction points in quality processes, so whether you’re a start-up or an established business, we can help you streamline compliance.
Reach out to our team of quality and regulatory compliance experts today“From day one, the MedQdoc team demonstrated a keen insight into the medical device industry and the pressure points a company like ours faces. They matched our needs to the platform’s capabilities, highlighting areas where MedQdoc could streamline processes and reduce friction. We came away confident that this solution was purpose-built with companies like us in mind — the team understood us and, more importantly, had the tools to propel our business forward.”
Espen Westgaard, CEO, Aidee Health AS
MedQdoc is used across the medical device industry
