#medtech #iso13485 #regulatory #deeptech #bioactivx #woundcare #biomaterials | Bioactivx® Today Bioactivx received our ISO 13485 certification. For a medical device startup, this is not just another compliance milestone. It is one of the most important foundations for bringing life-changing medical technologies to patients. This moment represents more than two years of relentless work by our team. It began in March 2024, when we started negotiating for access to an ISO-8 certified medical cleanroom at A*STAR so that we could manufacture our products under the strict standards required for medical devices. From there came: • Producing materials and samples for the full suite of ISO biocompatibility and safety tests • Writing and implementing hundreds of pages of Quality Management System (QMS) documentation • Building production processes that meet global medical device standards • Preparing every procedure, record, and traceability requirement needed for regulatory submissions In total, this journey took 18 months of preparation and another 6 months of audits. Every

Today, Bioactivx received our ISO 13485 certification - a critical foundation for bringing life-changing medical technologies to patients.
https://bax.bio/2s65pu
#MedTech #ISO13485 #Regulatory #DeepTech #Bioactivx

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Today, Bioactivx received our ISO 13485 certification - the foundation for bringing our synthetic regenerative biomaterials to patients.
https://bax.bio/2s65pu
#MedTech #ISO13485 #DeepTech #Bioactivx

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Grateful to host Prof Christopher Shen, Director of Stanford Biodesign & Fogarty Innovation. These sessions help guide us to translate synthetic regenerative biomaterials and prepare for global expansion.
https://bax.bio/GClmuE
#MedTech #StanfordBiodesign #WoundCare #Bioactivx

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A small key. A big step forward.
Today the Bioactivx received the keys to our new facility. With our flagship Bioactiv®️ Matrix moving through clinical and regulatory milestones, we’re entering the next phase: scaling for global demand.
https://bax.bio/B-tDMO
#Bioactivx #WoundCare #DeepTech

New Standard of Care: Fast, Clean, Culturally Agnostic. https://bax.bio/DO0uGB
#MedTech #WoundCare #Bioactivx

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We’re excited to announce our US$1.425M seed round funding to advance Bioactiv®️ Matrix. Fully synthetic, bio-inspired skin substitute for faster, safer healing.

https://bax.bio/FMBQEj
#Bioactivx #MedTech #DeepTech

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We’re thrilled to announce that Bioactivx®️ has joined A*StartCentral, A*STAR’s innovation community for deep-tech startups.

Read more https://bax.bio/8jC4r1
#Bioactivx #AStartCentral #Innovation #DeepTech #MedTech

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Case Study: Helping patients walk again .... faster.

Read more 👉 www.linkedin.com/posts/bioactivx_bioactiv...
#Bioactivx #WoundCare #MedTech #HealingFaster

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We’re thrilled to receive EnterpriseSG’s Startup SG Tech – Proof-of-Value Grant!

Full story 👉 www.linkedin.com/posts/bioactivx_bioactiv...
#Bioactivx #MedTech #Innovation