NovaQTech Insights
Modular Medical Receives Positive Notified Body Decision on ISO 13485:2016 Certification
Modular Medical, Inc. (NASDAQ: MODD) announced on 27 October 2026 that it has received a positive decision from its notified body regarding certification of its quality management system under ISO 13485:2016, the international standard for medical device quality management systems. The notified body is designated under the European Union Medical Device Regulation (MDR). The San Diego-based company is a commercial-stage medical device business preparing for the full commercial launch of its Pivot tubeless patch pump for insulin delivery. Chief Executive Officer Jeb Besser described the decision as an important milestone in the company’s preparation for CE Mark submission, which it continues to target for calendar year 2027. The company noted that ISO 13485 certification is separate from CE marking, which requires additional regulatory review, and that a CE mark under the MDR would allow it to pursue commercial distribution across the EU.
Source: ACCESS Newswire via FinancialContent — https://markets.financialcontent.com/stocks/article/accwirecq-2026-10-27-modular-medical-announces-positive-notified-body-decision-on-iso-134852016-certification