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Commercial and Quality

​Accelerate market access with quality and compliance at the core

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Regulatory Strategy

  • Outlines the plan to meet regulatory requirements for medical devices.

  • Should be developed early to ensure efficient use of time and resources.

  • Helps design products that meet country-specific regulations from the start.

  • Required under the EU Medical Device Regulation (EU MDR).

  • Experts can tailor strategies for compliance, faster approval, and lower costs.

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Technical / Medical Device File

  • MDF/TF is required for medical device and IVD submissions.

  • It includes design, testing, clinical data, and risk management.

  • ISO 13485 requires an MDF for each device type or family.

  • Content depends on device class, complexity, and country-specific rules.

  • MedtechBOSS helps with gap analysis, clinical reports, post-market docs, safety summaries, and full MDF setup.

Stack of Files

Quality Management Systems

  • QMS includes policies, procedures, and records based on internal rules for products/services.

  • We provide full QMS setup, document prep for certification, and audit support (RA/QA).

  • Our consultants are lead auditors with experience in various manufacturing sites.

  • We support compliance with standards like ISO 13485, SS 620, EU MDR, and FDA QSR.

  • Also cover MDSAP and UK Medical Device Regulation.

Bankruptcy Filing

Dealer License Tapping

  • MedtechBOSS is GDPMDS-certified with importer and wholesaler licenses.

  • Start-ups can use our licenses for import and distribution in Singapore.

  • This avoids the need to set up their own quality system.

  • It lowers costs and simplifies the process.

  • Our regulatory expertise ensures efficient market entry.

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