Alf Malmberg
Senior Quality and Regulatory Consultant

Alf’s foremost strength is creating quality management systems to an adequate compliance level, as well as maintenance and audits of the systems. Alf has a 30+ years of broad experience in working with quality assurance and regulatory affairs in medical device business, mainly in small companies developing new products.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Nils-Åke Lindberg
CEO and Co-founder, Principal 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.

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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.

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Robert Ginsberg
Senior Quality and Regulatory Consultant

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.

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