Company: QRA Medical (Vito Solutions Ltd)
Founder: Karandeep Badwal
Website: https://karandeepbadwal.com/
About QRA Medical (Vito Solutions Ltd)
QRA Medical is an independent MedTech regulatory and quality consultancy founded by Karandeep Badwal and based in Solihull in the West Midlands. The company helps SME manufacturers and Software as a Medical Device companies take products from concept to market across the UK, EU and US, covering FDA pathways including 510(k) and De Novo, EU MDR, IVDR, UKCA, ISO 13485 quality management systems and IEC 62304 software lifecycle compliance, with a particular focus on AI and machine learning enabled devices.
The problem QRA Medical set out to solve is simple. MedTech products rarely fail because of one dramatic mistake. They fail because early product development decisions are made without anyone in the room understanding what those decisions mean for the regulatory pathway, the evidence required and the route to market. Founders discover the consequences late, when they are expensive or impossible to unwind. Regulatory gets bolted on at the end instead of being designed in from the start, and much of the consulting industry profits from making the whole thing feel more complicated than it actually is.
QRA Medical does the opposite. The company translates dense regulatory frameworks into plain language and exact actions, strips away the requirements that do not apply to a given product and explains why each remaining one matters. Clients get a clear line from the decisions they are making today to the submission, audit and market entry waiting further down the road. In reality that means classification strategy, quality system builds, technical documentation, remediation, audit support and regulatory submissions delivered end to end, whether the product is a traditional device or a machine learning model that will keep changing after it reaches the market.
The impact reaches well beyond direct client work. Karandeep hosts The MedTech Podcast, interviewing founders, regulators and industry leaders from around the world. He judges for MedTech Innovator, the largest MedTech accelerator globally, assesses grant applications for Innovate UK, guest lectures at universities and trains regulatory professionals across the industry through Bywater. His LinkedIn commentary on medical device regulation has made him one of the most followed independent voices in the sector, read daily by the founders, CEOs and quality managers the industry depends on.
The biggest challenge has been proving that a lean independent consultancy can outperform the big names, and the answer has been the work itself. The philosophy is that a QMS is built not bought and that quality is a culture not a department. Companies that understand this get to market faster, survive audits and build products regulators trust. QRA Medical exists to get them there.
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