The Challenge
In the face of significant regulatory changes, transitioning legacy products into a compliant state under new regulations is easier said than done. The shift in EU regulations from MDD to MDR is a poignant example, with many manufacturers deciding to sunset their products rather than tackle the difficulties of meeting more stringent requirements.
Apoplex put significant effort into transitioning its SRA technology under the EU MDR but still faced challenges during its conformity assessment. It was then that Apoplex turned to Dovetail to help get the product over the line through the compliance process with its notified body.
Dovetail brought in embedded regulatory staff to engage with the notified body, set clear timelines for responses to reviewer questions, and polish the technical documentation under circumstances that required quick execution. Dovetail was tasked with ensuring the technical documentation reflected all updated MDR requirements and was ready for the EU market.
The Solution and Outcome
Dovetail works alongside Apoplex as an end-to-end regulatory and quality partner. The collaboration gave Apoplex a distinct advantage at a critical point in its device journey.
Regulatory front of house
Dovetail quickly established a relationship with the notified body reviewing Apoplex's device to understand expectations and set reasonable timelines for reviewer responses. At the same time, Dovetail coordinated with the Apoplex team to assemble and organize the evidence required by the reviewer.
Next-generation tooling and efficiency
Apoplex's existing QMS and technical documentation were quickly integrated with Dovetail's eQMS to assess and respond to notified body questions. Along with a dedicated chat channel, the eQMS's embedded tooling allowed Dovetail's team to turn around revised, compliant documentation while staying in close collaboration with Apoplex's team so no detail was missed.
No need for regulatory hires
Dovetail was able to stand in for Apoplex's regulatory team during the conformity assessment for its EU MDR product. This meant Apoplex could immediately start work on ensuring complete conformity for its product in a time-critical situation without having to rely on a hiring process.
Zero non-conformities
The Dovetail team resolved the notified body reviewer's open questions, bringing the technical review down to zero non-conformities after only one round of updates and review. This saved Apoplex significant time and resources, enabling the company to advance its product toward market access under the new MDR requirements sooner.
Apoplex asked Dovetail to step in at a critical moment for its product. In a matter of weeks, Dovetail de-risked the submission and aligned all requirements, eliminating all non-conformities and progressing the SRA pro product toward successful market access within Apoplex's required timeline and budget.
Dovetail continues to plan and execute Apoplex's US FDA regulatory submission program.
