Quality & Regulatory Team

Mattias Kyhlstedt
CEO

CEO and Founder of Synergus AB and Synergus Corp
15 years of experience in Quality & Regulatory and Reimbursement in the medical device industry
Unique management knowledge and insights within medical device companies based on previous positions within business development, production, quality, logistics and R&D in global corporations as well as start-ups
Considerable experience in development of Pan-European regulatory and reimbursement strategies for medical device companies
Frequent speaker at various international conferences in the area of reimbursement and Quality & Regulatory

Alf Malmberg
Senior Expert - Biocompatibility

Long experience in Quality Assurance and Regulatory Affairs within medical device technology including risk analysis (ISO-14 971) and biocompatibility evaluation
Wide experience in creating quality systems to adequate levels, implementation and audit of the systems and their use.
Doctor in Organic Chemistry and a background in chemical research with a great understanding of the chemical processes and the problems associated with these
Specific experience of standards, Quality Assurance and validation of development and production processes for class III products, including combination products and implants

Lian Zhang
Senior Expert - Quality & Regulatory Management

Vast experience in the regulatory field for in vitro diagnostic medical devices and medical devices in the EU, China, Taiwan, Japan, S. Korea and U.S. to mention a few, regarding conformity assessment, product documentation for registration submission, labelling, regulatory assessment with product modification, project support with regulatory issues and ISO13485 compliance
Foremost strength is strategic work that leads to regulatory compliance within product development and successful product registrations in the concerned countries
With good competence in Regulatory Affairs, this is a valuable resource in opening new markets for your business growth
Special focus on the Chinese and Taiwanese markets where he has an extensive experience combined with fluent Chinese

Nils-Åke Lindberg
Senior Expert - Quality and Regulatory Management

More than 25 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, project management.
Provides extensive international practical experience from quality system implementation and regulatory 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, recall/FSCA.
With the industrial management background provides hands-on support in applying standards, regulations and addressing quality and regulatory issues. He can help prioritize to obtain fast but not overly complex compliance. He also provides support and management of larger quality and regulatory projects and strategies. For example Regulatory strategies at mergers of MedTech companies.
Nils-Åke provides experience from supplier reviews, supplier contracts, and ww supply chain management, site establishment.
Provides European Authorized Representative services for non-EU based medical device manufacturers.

Robert Ginsberg
Senior Expert - Lean SW Development and Design Control

25 years experience in software engineering, 17 years working for leading medical device companies. Has been responsible for developing and maintaining processes at software departments of medical device companies
Worked with adaption of development processes for medical devices to modern software engineering practices, e.g. RUP, Xp, Scrum and Lean development in compliance with regulatory requirements. Most recently he has implemented agile SW development (Scrum) in combination with IEC-62304 at a global pacemaker company
Actively participating in the whole process of the development of the IEC/ISO 62304 standard in the international committee. With extensive experience in the industry and involvement in the standardization work he holds a unique position to provide support in how to understand and interpret the 62304 standard
Long experience and unique understanding on how to evolve a software process of a medical device manufacturer to comply with 62304, and use the most productive software engineering practices at the same time

About us

Synergus AB Svärdvägen 19
182 33 Danderyd/Stockholm
+46 (0)8-544 767 50