Device Advice & CERS is located in Brisbane, Australia.
The company founder, Daniela Sanders, saw a need in the medical device industry for experienced Regulatory Affairs consulting to assist companies with a wide range of services.
Daniela has been consulting for two years for Australian and Global medical device firms. She has helped a large number of companies from small startups to large international medical device manufacturers.
Experience Snapshot: Senior Regulatory Affairs & Team Leader - Cook Medical (12 years) - Global regulatory strategist, Clinical Evaluator for Class I, IIa, IIb/IIb Implantable, III inc. drug containing devices. Technical FIle and Design Dossiers for CE marking, Clinical Evaluation Reports to MEDDEV 2.7.1 Rev 4. Australian registrations (400+), all classes, inc. full conformity assessments, for drug, human and animal product containing devices. Regular communication with multiple departments at TGA. Expert in written Regulatory communications of all types. Chinese Clinical Evaluation Reports. New device development.
FDA Reviewer - Safety Evaluator in the Office of Drug Safety - CDER (2 years) - Cardio-renal drugs
Registered Pharmacist (current) with a post-graduate qualification in Clinical Pharmacy. Six years working in UK and Brisbane hospitals including general medicine/medical admissions, cardiology/CCU, Surgical/orthopedic/ENT. Research Pharmacist for the Brisbane Cardiac Consortium.
TESTIMONIALS
"Daniela has been providing regulatory advice to our company for several months now. She has helped to review our product documentation and our website to ensure regulatory compliance.We have found her to be very knowledgeable, diligent and practical in her approach to our projects.”
Blake, CEO
“I have worked with Daniela for many years and she has always demonstrated a professional and friendly approach to her work. Daniela has a wonderful blend of pharmaceutical and medical device knowledge and experience. Daniela's experience and understanding of the CE Mark regulatory process from Cook Medical along with her time working at the FDA in pharmaceuticals, give her a strong knowledge position in the ever changing area of drugs and devices and the many ways they may come together.Recently Daniela helped our company to edit and QC a number of regulatory related procedures.”
Michael, Director of Quality of a start-up medical device/biologics company.
Daniela is a highly skilled and experienced professional. Daniela is reliable and takes a task based approach to her projects and delivers on commitments efficiently and with transparency. Most recently, Daniela has helped us review and update class III clinical evidence reports for Europe and Australia.
GM and Executive Director
Multi-national medical devices company
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Clinical evaluation reports for TGA, CE marking (MEDDEV 2.7.1 Rev 4), CFDA - medical writing/systematic literature reviews
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MDD/MDR Post-Market Surveillance, PMCF
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CE Marking - Class I to III medical devices
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MDR advice, plans, training
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Australian Medical Device Registrations
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Regulatory plans for new devices
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Classification
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Advice for start-ups
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Regulatory documentation, editing & review