Black Week has arrived — and so has your chance to boost your regulatory compliance, team capability, and global market access at an exceptional price.
For one week only, MedKaizhen offers 20–50% discounts across our most in-demand services, supporting medical device manufacturers worldwide.

Whether you are strengthening your team’s regulatory knowledge, preparing for international approvals, or accelerating your market entry, this is the ideal moment to invest.

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🌟 Priority Offer: e-Learning for Regulatory Affairs

50% OFF
Explore our full course library:
 

Our e-Learning programs deliver clear, practical, and up-to-date regulatory guidance across international markets.
Perfect for regulatory beginners, experienced specialists seeking updates, and companies training teams across multiple locations.

Why choose our Academy?

• Self-paced online modules with one to one coach

• Global regulatory content (EU, US, China, ASEAN, and more)

• Practical examples and documentation know-how

• Ideal for onboarding and continuous upskilling

• Free session

 

💡 Workshops & Training — Hands-On, Interactive Learning

20–30% OFF
Browse workshops:
 

For teams that need deeper understanding and case-based training, our workshops are designed to provide clarity on complex topics such as clinical evaluation, technical documentation, PMS, risk management, and global registrations.

We offer:

• Online and on-site workshops (Germany, Swiss, France)

• Team training packages

• Custom programs tailored to your product and market

 

🌍 International Market Access Services

20–30% OFF
Learn more:
 

Whether you target Europe (MDR/IVDR), FDA (US), China (NMPA), Southeast Asia, or other global markets, we help you navigate regulatory pathways efficiently.

Our support includes:

• EUDAMED registration

• CE marking support

• NMPA dossier preparation

• Regulatory gap analysis

• Distributor qualification & compliance

This Black Week discount makes it easier to enter new markets with the right regulatory strategy.

 

🔧 Interim Manager for Regulatory Affairs & Quality Management

Flexible RA/QM Support — Part-Time, Project-Based, or Hourly
 

MedKaizhen provides immediate RA/QM support for companies facing resource gaps, audits, submissions, or temporary vacancies. Ideal for HR teams needing fast, reliable expertise without long recruitment cycles.

For HR & Hiring Managers

We support:

• Part-time RA/QM (8–20 hrs/week)

• Project-based consulting

• Hourly/contingency support

• Temporary RA/QM leadership

• Backfill during recruitment or leave

Where We Help Most

• Technical documentation

• MDR/IVDR remediation

• Audit preparation (NB, MDSAP, NMPA)

• EUDAMED tasks

• PMS/PMCF setup

• QMS/SOP improvement

• Global market approval support

 

📄 Compliance Templates — Ready-to-Use, Fully Editable

20–40% OFF
Templates available here:
 

Save time and reduce documentation errors with our professional templates, covering:

• Technical documentation

• Device description

• Clinical evaluation

• PMS/PMCF

• SOPs and procedures

Ideal for fast implementation, internal audits, or preparation for MDR/IVDR transitions.

 

Why Black Week Is the Best Moment to Invest

• Regulatory expectations keep rising — preparation is essential.

• Skill gaps and documentation issues are among the top audit findings; training and templates help prevent them.

• A 20–50% discount means your team can improve capabilities at a fraction of the usual cost.

• All services create long-term value: faster approvals, fewer compliance risks, and stronger global competitiveness.