Symbioteq offers regulatory affairs and quality assurance consultancy services and staff training for medical device and in-vitro diagnostic device companies.
Its team of experts has an in-depth knowledge of current international medical device regulations and has a thorough understanding of the necessary regulatory prerequisites for registration submissions to regulatory bodies.
Symbioteq participates in standardisation committees covering areas such as quality systems, risk management, biological safety, medical software, medical aid, active devices, and clinical evaluation.
MDR and IVDR compliance
Symbioteq has an extensive knowledge of regulatory changes currently taking place in the EU with the implementation of medical device regulation (MDR) and in-vitro diagnostic device regulation (IVDR).
Assisting with regulatory strategy gap analysis and establishing technical files, Symbioteq helps companies meet new requirements for both new products and devices that already have a Conformité Européene (CE) mark.
Global regulatory strategy and compliance
Symbioteq has in-depth knowledge of current international medical device regulations and assists companies with regulatory submissions and market access in the EU, the US, Canada, Australia, Asia and the Middle East.
Services available include the establishment of regulatory strategy, product files (technical files and design dossiers), classifications and regulatory submissions.
Quality management system development
Symbioteq is experienced in developing, implementing and streamlining quality management systems (QMS) to ensure that content and structure meet international regulatory requirements.
The company is experienced with global quality system requirements, including ISO 13485, quality system regulation (QSR), Medical Device Single Audit Programme (MDSAP) guidelines, MDR and IVDR.
Symbioteq also conducts mock audits for MDSAP, MDR, IVDR and QSR.
Biological evaluation consultation services for medical devices
Symbioteq offers biological evaluation consultation services, including the establishment of a biological evaluation plan and report in compliance with ISO 10993.
As part of this service, Symbioteq assists with the selection of raw materials, coordination of studies at test laboratories, suggests and reviews chemical characterisation, and performs toxicological risk assessments.
Clinical evaluation services
Symbioteq provides clinical evaluation services in preparation for CE marking and as part of post-market surveillance.
The company performs literature search / reviews and creates a clinical evaluation plan (CEP) and clinical evaluation report (CER) that meets MEDDEV 2.7/1 revision 4 and MDR requirements.
Symbioteq also conducts a performance evaluation to meet IVDR requirements.
Staff education and training for medical device regulation
Symbioteq has a broad programme of regulatory affairs and quality system training for the medtech industry, including courses such as The New European Regulatory Landscape MDR and IVDR, ISO13485, Design Control, QA / RA Leader and Auditor / Lead Auditor.
The open courses can also be customised to meet a client’s individual needs.
EU authorised representative of medical device manufacturers
Symbioteq acts as an EU authorised representative for non-European manufacturers of medical devices without an establishment in the EU.
Symbioteq has more than 20 years’ experience in medical device regulations and has assisted more than 500 medical device companies with regulatory compliance.
As a member of standardisation committees and EU workgroups, Symbioteq provides its clients with early insights on new regulatory requirements in the medical device industry.