Get the device to market without guessing.
Regulatory Affairs ConsultingBrightbark Cranberry works with medical device and IVD manufacturers to solve regulatory challenges, focussed on EU and UK requirements.
We used to be the people reviewing your file. Now we help build strategies, documentation and audit responses that hold up under pressure.
Do we need a consultant, or can we do this in-house?
Many manufacturers can. The regulations are public, the guidance is published, and a competent quality team can work through most of it. Where an outside consultant earns the fee is pace and avoided rework — a rejected technical documentation submission costs you a review cycle, not just a fee. If you're not sure which side of that line you're on, say what you're working on and we'll tell you honestly.
Common QuestionsWe've had a notified body nonconformity — can you help with the response?
Yes. Whether it’s a nonconformity against ISO 13485 or a deficiency question raised during technical documentation review, we have the experience to create a robust plan and manage the response. We’ve written responses and assessed them from the notified body side of the table. We can assist you in closing gaps quickly, and ensuring they don’t reoccur.
Can you do the work, or do you only advise?
Both, depending on what's useful. Some clients want documentation written; others have drafts and want them reviewed before they go anywhere near a notified body; others want someone in the room during an assessment. Scope is agreed in writing before anything starts.
You’re in experienced hands.
Our People
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years at a leading notified body.
DIRECTOR
“Success in your regulatory submissions is built on skills and experience - and we can be your partner to provide them.”
Regulatory affairs, with insider knowledge.
Services for Regulatory Affairs
If it’s not listed here, we can still help.
EnquiriesDrop us a message with your needs, and we’ll let you know what we can offer. We’ll respond within 48 hours.