We can help
With over 12 years in regulatory affairs and quality assurance, we have been a trusted guide helping numerous MedTech companies obtain and/or maintain market approvals with nimble proven strategies that assure right the first-time results.
Our clients increase their speed to market, eliminate accumulated system inefficiencies, reduce overall RA/QA cost; and expand market coverage and access to more than a billion people with the CE mark alone.
For each of our clients we demystify the regulations and provide a practical approach guaranteed to achieve agreed upon product and quality management certification goals.
Start today, contact us to accelerate the effectiveness if your RA/QA work and advance medical care in your markets.
What is Unique about QARALOGIC
Our experience and skillset make us the ideal bridge to Europe and Asia
EU Regulation Expertise
Based in Canada, with experience bringing North American MedTech innovation to Europe and Asia
Mastery of US FDA and Health Canada technical documentation including overlaps with EU requirements
Experience CE Marking Medical Devices and dealing with EU Competent Authorities incl. export/import requirements
Qualified PRRC, educated in Europe and speaks English, French and German
In-depth knowledge of MDSAP, 21 CFR 820 and ISO 13485:2016
Available for in-person audit support and experience with US FDA, Health Canada, ANVISA, NBs (G-MED, BSI, TUV, SGS) audits
Asian Market Knowledge
Experience qualifying OEMs and managing Distributors including product registrations
Experience working in Asia
(a total of 5 years)
Assurance to achieve agreed upon product and quality management certification goals
We support from Fortune 500s to research institutes. Past companies we've helped include P&G, Livanova, BC Cancer, Novadaq, Stryker, Sanofi and I-MED Pharma
So, why us instead of an EU-based consultant
We get often asked the question, and while we understand the logic behind your concern, there are crucial aspects to account for that only a North-America based EU regulations expert can help you with. This is particularly important to avoid redundancies in testing, technical documentation and overall certification process duplication which ultimately result in significant cost saving.
To help you think this through, we are happy to discuss key considerations you might want to account for when making your decision on the best advisors to take you through the CE Marking and company's global expansion.