meditec Consulting was established in 2004 in Switzerland.

We specialize in regulatory and quality consulting services throughout the product life-cycle to help manufacturers comply with these regulatory requirements. Our consultants have many years’ experience with different regulations in various countries for medical devices, in-vitro diagnostics, combination products, pharmaceuticals and biologics.

Our customers are committed to develop and market healthcare products that meet high quality standards. Already facing technological challenges, companies must also keep pace with the evolving regulatory environment worldwide.

Do you want to learn more about our services or request a quotation? Contact us

Our Team

Sandra Soniec Founder and Managing Director,regulatory affairs professional since 1999
Education

Biomedical engineer, University of Applied Sciences Luebeck, Germany

Core competencies

RA strategy, medical device and IVD regulations, preparation and submission of technical documentation for EU, USA and Canada, Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, FDA inspections, Notified body audits, Device Vigilance reporting, Risk- and Usability management

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Dental, Anesthesiology, Medical device software

Nadine Schwarz Senior Consultant,
regulatory affairs professional since 1999

Education

M.Sc. Chemistry (lic. phil. nat.),
University of Berne, Switzerland

Core competencies

RA strategy, medical device, IVD and pharmaceutical regulations, preparation and submission of technical documentation for  EU, USA, Canada and Australia, Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, Notified body audits, Device Vigilance reporting, Packaging Validation, Risk- and usability management

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Biologics, Veterinary medicines, IVDs, Research Use Only (RUO) products, Drug Master Files (EU & US)

Céline Malo Senior Consultant,
regulatory affairs professional since 2005

Education

M.Sc. Biochemistry, National Institute of Applied Sciences (INSA) Lyon, France

Core competencies

RA strategy, medical device and IVD regulations, Preparation and submission of technical documentation for  EU, USA, Canada and international markets (LATAM, ASEAN, Japan), Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, Notified body audits, Submission management for pharmaceuticals, EU/CH Pharmacovigilance

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Dental, IVDs, Pharmaceuticals, Biologics

Bettina Herrmann Senior Consultant,
QM and QA professional and trainer since 1998

Education

M.Sc. Molecular Biology, University of Basel, Switzerland

Core competencies

Quality system compliance in accordance with ISO 13485 and FDA QSR, conformity of processes and their practical application, FDA inspections, Notified body audits, Project Management, strategy and carrying out of documentation, technical files in development projects, training, change management and CAPA

Product related experience

Drug delivery devices, Combination products, Vaccines, Blood Plasma

Brigitte Daxelhoffer Consultant,
regulatory affairs professional since 2010

Education

Regulatory Affairs Manager Medical Device (EU), University of Lübeck
Psychologist, University of Applied Science Olten, Switzerland
Nutritionist, University of Applied Science Berne, Switzerland

Core competencies

Regulatory Intelligence, eCTD Dossier Publishing, Variations in CH, Experience in: Quality Assurance, International Clinical Research, Pharmacovigilance, Training and Coaching

Product related experience

Pharmaceuticals, Biologics

Mary Sinnott Senior Consultant,
regulatory affairs professional since 2005
Education

M.Sc. Analytical Chemistry, Waterford Institute of Technology, Ireland
B.Sc. Applied Chemistry, Liverpool John Moores University, UK.

Core competencies

Global product regulatory strategy for Medical device and Drugs, preparation and submission of technical documentation for EU and USA (incl. PMA, NDA, MAA). Regulatory support for ROW markets, including Brazil, Mexico, Japan and China.
Quality system compliance in accordance with ISO 13485, CMDCAS, PDMA and FDA QSR, FDA inspection, Notified Body audits and MAH audits. Internal audit execution, project management, Business system definition and implementation. Business excellence and management. Coaching and mentoring.

Product related experience

Medical devices (class II implants) and Combination products (class III implants), Synthetic and Biologic human medicines, Blood products.

Andreas Wallusch CIO, CFO and Business Partner

Education

Dipl. Physics, Georg-August-Universität Göttingen, Deutschland

Core competencies

IT-Services, Finance, Accounting, Controlling

Sandra Soniec Founder and Managing Director,
regulatory affairs professional since 1999
Education

Biomedical engineer, University of Applied Sciences Luebeck, Germany

Core competencies

RA strategy, medical device and IVD regulations, preparation and submission of technical documentation for EU, USA and Canada, Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, FDA inspections, Notified body audits, Device Vigilance reporting, Risk- and usability management
Product related experience

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Dental, Anesthesiology, Medical device software

Nadine Schwarz Senior Consultant,
regulatory affairs professional since 1999
Education

M.Sc. Chemistry (lic. phil. nat.),
University of Berne, Switzerland

Core competencies

RA strategy, medical device, IVD and pharmaceutical regulations, preparation and submission of technical documentation for  EU, USA, Canada and Australia, Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, Notified body audits, Device Vigilance reporting, Packaging Validation, Risk- and usability management

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Biologics, Veterinary medicines, IVDs, Research Use Only (RUO) products, Drug Master Files (EU & US)

Céline Malo Senior Consultant,
regulatory affairs professional since 2005
Education

M.Sc. Biochemistry, National Institute of Applied Sciences (INSA) Lyon, France

Core competencies

RA strategy, medical device and IVD regulations, Preparation and submission of technical documentation for  EU, USA, Canada and international markets (LATAM, ASEAN, Japan), Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR, Notified body audits, Submission management for pharmaceuticals, EU/CH Pharmacovigilance

Product related experience

Drug delivery devices, Combination products, Cardiovascular, Orthopedics, Dental, IVDs, Pharmaceuticals, Biologics

Bettina Herrmann Senior Consultant,
QM and QA professional and Trainer since 1998

Education

M.Sc. Molecular Biology, University of Basel, Switzerland

Core competencies

Quality system compliance in accordance with ISO 13485 and FDA QSR, conformity of processes and their practical application, FDA inspections, Notified body audits, Project Management, strategy and carrying out of documentation, technical files in development projects, training, change management and CAPA

Product related experience

Drug delivery devices, Combination products, Vaccines, Blood Plasma

Brigitte Daxelhoffer Consultant,
regulatory affairs professional since 2010
Education

Regulatory Affairs Manager Medical Device (EU), University of Lübeck
Psychologist, University of Applied Science Olten, Switzerland
Nutritionist, University of Applied Science Berne, Switzerland

Core competencies

Regulatory Intelligence, eCTD Dossier Publishing, Variations in CH, Experience in: Quality Assurance, International Clinical Research, Pharmacovigilance, Training and Coaching

Product related experience

Pharmaceuticals, Biologics

Mary Sinnott Senior Consultant,
regulatory affairs professional since 2005
Education

M.Sc. Analytical Chemistry, Waterford Institute of Technology, Ireland
B.Sc. Applied Chemistry, Liverpool John Moores University, UK.

Core competencies

Global product regulatory strategy for Medical device and Drugs, preparation and submission of technical documentation for EU and USA (incl. PMA, NDA, MAA).  Regulatory support for ROW markets, including Brazil, Mexico, Japan and China.
Quality system compliance in accordance with ISO 13485, CMDCAS, PDMA and FDA QSR, FDA inspection, Notified Body audits and MAH audits. Internal audit execution, project management, Business system definition and implementation. Business excellence and management. Coaching and mentoring.

Product related experience

Medical devices (class II implants) and Combination products (class III implants), Synthetic and Biologic human medicines, Blood products.

Andreas Wallusch CIO, CFO and Business Partner
Education

Dipl. Physics, Georg-August-Universität Göttingen, Deutschland

Core competencies

IT-Services, Finance, Accounting, Controlling

Partner Network

meditec Consulting is member of an independent network
of consultancies for the medical device industry.

Our approach

Together with you, we develop and implement solutions tailored to your individual needs.

Your benefit

  • all our expertise with just one contractual relationship
  • many years’ experience and joint know-how
  • well-rehearsed flexible teams

our active participation in professional associations and experience group