Anna-Karin Areskog
Senior Quality and Regulatory Consultant

Anna-Karin has a medical background and has worked many years as QA manager within medical device and the pharmaceutical industry. She is a calm and experienced QA/QC professional, highly appreciated by clients for her positive approach in all kind of stressful situations.

show more

Specifically, Anna-Karin is supportive within ISO 13485, GMP, QSR, trainings, production processes, specs, purchasing, process/equipment validations, cleanroom validation. Anna-Karin holds a Masters degree in quality for life science, chemical engineering and is a registered nurse.

“Having spent considerable time with remediation work and helping companies out of compliances issues with FDA. – How do you recommend MedTech companies to avoid such situations?”
”Serious compliance issues cost companies tremendous amount of time, money and goodwill. Medtech companies simply must realize and respect to do things in a correct and compliant way from design start and throughout the product lifecycle.”

More about Anna-Karin | LinkedIn

show less

Cecilia Emanuelsson
Senior Quality and Regulatory Consultant

Cecilia has extensive experience from the medical device industry and from academic research. She is regarded as professional, highly competent, distinct in oral and written communication and fast in understanding new areas.

show more

Cecilia has specific expertise in clinical evaluations, patient safety issues, clinical risk/benefit analyses, usability aspects and scientific reviews.
Cecilia holds a PhD and an MScPharm from Uppsala University, where she is also appointed associated professor.

“A clinical evaluation is required by the MDD for demonstration of conformity with the essential requirements. How do you recommend companies to handle this?”
”I recommend to start with the clinical evaluation already in the initial phases of product development. Early identification of the need for clinical data to ensure safety and performance of the device makes it possible to plan for clinical studies well in advance.
In the long run, a well performed clinical evaluation saves time and money as well as enhances product quality.”

More about Cecilia | LinkedIn

show less

Cilla Lundevall
Senior Quality and Regulatory Consultant

Cilla has 18 years of experience from the Medical Device field, mainly from Agile product development and testing but also from technical service and sales support. The intellectual property domain is also an area wherein Cilla can contribute with her knowledge.

show more

Cilla is known as thoughtful and cares about details. She is proactive and takes a comprehensive and goal-driven approach to her assignments. Cilla is highly communicative and honest in her approach. Cilla is certified SW tester (ISTQB) and certified SAFE™ Program Consultant (Scaled Agile Academy).
“What approach gives the best compliance?”
”Compliance for me is not just to follow the rules, it is about getting down to the rationales. When you understand why the rules are there, you will be able to tailor the application smoothly to your specific products. You will also find that your products will really benefit from it by increased quality and efficacy.”

More about Cilla | LinkedIn

show less

Ferenc Dahnér
Senior Quality & Regulatory Consultant

Ferenc has over 15 years’ experience of quality and regulatory management including product development, and authoring and review of medical device labeling. Ferenc also has a long experience with global regulatory requirements including product registrations.

show more

Ferenc is perceived as communicative and professional in his roles. With his long and broad experience he easily grasps new issues and finds constructive “outside the box” solutions. He is well versed in the regulatory requirements and has a talent to find the least burdensome approach.

“A lot of companies have excellent quality management systems in a binder on the shelf, but many seem to have problems getting a genuine acceptance and compliance throughout the organization. What is your advice to avoid this when setting up a quality management system?”
”I think that it all comes down to being humble and showing people respect and give them acknowledgement for their competency by involving them in the work. Even though you´re hired because of your knowledge in QA it doesn’t mean that you know everything. If you try to tell experienced employees how to do their job they will naturally be offended. So help THEM implement a QMS system by supporting them with regulatory knowledge, instead of telling them what to do. When you think of it, its common sense. Isn´t it?”

More about Ferenc | LinkedIn

show less

Hedvig Tuxen-Meyer
Senior Quality and Regulatory Consultant

Hedvig has 30+ years of experience from working with medical devices and other life science products, including product development, quality assurance and process improvements. Hedvig is appreciated for her deep knowledge, thoroughness, analytical mind and amiability.

show more

She has specific competence in requirements design and analysis, risk analysis and verification/validation in accordance with MDD and QSR.

Hedvig holds an MSc Engineering Physics from the Royal Institute of Technology in Stockholm and is a certified Requirements Analyst (REQB) and certified SW Tester (ISTQB).

“Many companies struggle with getting their medical device on the market, which requires fulfillment of many regulations and standards. How do you recommend MedTech companies to handle this?”
”Classify your product early during the development to define what is needed to fulfill the regulations. This has big impact on the whole project; the level of documentation, verification, validation, risk analysis etc.”

More about Hedvig | LinkedIn

show less

Maria Rickardsson
Senior Quality and Regulatory Consultant

Maria has over 20 years of experience in regulatory frameworks, quality assurance and risk management gained from the medical device, software and telecom industries both in small start-ups and large international companies.

show more

She is a team player focused on deliver quality on time. With her long and broad experience, she easily grasps new issues and finds constructive solutions.

Specifically, Maria is supportive within ISO 13485, ISO 14971 and IEC 62304. Maria holds a masters degree in Electrical Engineering from Chalmers University of Technology. In addition, Maria is a certified scrum master and an expert representative on various international standardization committees for medical device software and medical device IT networks (IEC 62304, IEC 82304, IEC 80002 series and IEC 80001 series)

“I have a great idea on a revolutionary Medical Device! When should I first consider regulatory and compliance scenarios?”
Now! Get yourself an understanding of the demands so that they can be considered and included in the planning. To initially include the regulatory requirements will increase the chance of success. If you wait until the product is almost ready is a great risk having to redo parts and get caught up in time consuming procedures. ”

More about Maria | LinkedIn

show less

Mikael Dahlke
Senior Quality and Regulatory Consultant

Mikael has 20+ years of experience of the entire chain for product development (from requirements to verification/validation of the product), process improvements, quality assurance and regulatory approvals. He has developed strategies for global regulatory submissions.

show more

He is often engaged to conduct analyses, planning and implementation of product development and process improvement projects.

Mikael holds an MSc in Electrical Engineering from the Royal Institute of Technology in Stockholm and is Certified Lead Auditor (ISO 13485). He is a member of the Swedish national standardization committee for IEC 60601-1 and related standards.

““Our company cannot manage all the requirements from regulatory bodies. It is only about producing paper, nothing that benefits our customers.””
”My mantra is to work risk-based. Always start with the risk analysis. Concentrate your efforts where there is the highest potential to cause harm. In the end you will notice that focused efforts have increased safety of your product and streamlined your development.”

More about Mikael | LinkedIn

show less

Nils-Åke Lindberg
CEO and Senior Quality and Regulatory Consultant

Nils-Åke has over 30 years of experience in the Medical Device industry. He has long management experience of Quality Assurance and Regulatory Affairs but also senior management positions within production, technical services and development.

show more

Nils-Åke provides support for top management as well as line staff in a multitude of aspects to both large corporations and start-ups. It may be regulatory strategies or compliance projects on both local and corporate level.

He has in-depth experience from active relationship with Competent Authorities and the FDA in complex situations involving warning letter, import detention, adverse events, FSCA/recalls. He is responsible for the company’s European Authorised Representative services.

Nils-Åke holds a MSc in Electrical/Biomedical Engineering from Lund Institute of Technology. He is a member and participant of European Association of Authorised Representatives (EAAR) and EU work group. Active member in SIS/TK355, and international TC201/WG1 standard committee for Medical Quality Systems.

“How do you advise small and medium size MedTech companies to best navigate in sometimes troubled regulatory waters?”
Increased authority focus on medical devices meeting state-of-the-art in standards and industry guidelines nowadays requires comprehensive and diverse regulatory competence. It is challenge for QA&RA professionals keep abreast of the current requirements. This fact should not be underestimated and need for external expertise should be planned. Clearly defined and understood, regulatory requirements up front will reduce the risk of delays of marketing introduction.”

More about Nils-Åke | LinkedIn

show less

Per Sundström
Senior Quality and Regulatory Consultant

Per has 20+ years of experience from the medical device & medical IT industry, from small startups to large international companies. He has extensive knowledge of product life cycle management and product development, especially with focus on software, but main competencies also include general management, business and process development.

show more

Per is exceptionally good at grasping complex scenarios and transform these into innovative solutions and plans, and is usually described as goal oriented, energetic and enthusiastic with a humble attitude.

Per holds an MSc in Electrical Engineering from the Lund Institute of Technology and is a member of the Swedish national standardization committee for IEC 80001-1 and related standards.

“How can we develop products faster with shorter deadlines and increasing regulatory requirements?”
Over the years I have seen that if you early on work through requirements, pay attention to risk analysis, keep options open as long as possible and plan for change it will always pay off at the end of projects so my recommendation is: “Think slow – Act fast – Embrace Change!”

More about Per | LinkedIn

show less

Robert Ginsberg
Senior Quality and Regulatory Consultant and Chairman of the Board

Robert has 25+ years of experience of software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods at several companies.

show more

He is often engaged to conduct product and software risk analyses, improve way of working and find and efficient level of compliance.

Robert holds an MSc in Technical Physics from Uppsala University and is Certified Lead Auditor (ISO 13485 and QSR). He is a member of the Swedish national standardization committee for IEC 62304 and related standards.
“Can we work in an iterative way in a regulated environment?”
”Yes, Lean and regulatory expectations can go hand in hand.

My mantra is to work iteratively in small steps, gaining feedback and continually improve the way of working. Always start with the vision where to go, taking baby steps in that direction. Concentrate your efforts where there is the highest potential to leverage quality and value. At the end you will notice that iterative techniques can improve compliance, quality and time-to-market of products.”

More about Robert | LinkedIn

show less