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Terms & Conditions

1. Definitions

In these Terms and Conditions:

  • "Company" means QualiSure Consulting Ltd, registered in England and Wales (Company No. 16347609).

  • "Client" means the entity purchasing Services under this Agreement.

  • "Services" means consultancy, training, or advisory work as defined in Clause 3.

 

2. Basis of Contract

2.1 This Agreement governs all Services provided by the Company.
2.2 The Statement of Work or written quotation constitutes the binding scope of Services.

 

3. Services

3.1 Consultancy Services

The Company provides:

  • QMS Implementation & Auditing (ISO 13485:2016, ISO 9001:2015)

  • Regulatory Compliance Support (EU MDR/IVDR, FDA Submissions)

  • Technical Documentation Reviews

  • MDSAP Preparation

3.2 Service Tiers

  • Stage 1 Preparation: £65/hour

  • Stage 2 Preparation: £85/hour

  • MDSAP Preparation (1-2 Jurisdictions): £85/hour

  • MDSAP Preparation (3+ Jurisdictions): £100/hour

  • FDA Submission Support: £100/hour

 

3.3 Training Services

3.3.1 Scope

The Company delivers:

  • ISO 9001:2015 Clause-by-Clause Training: £50/hour

  • ISO 13485:2016 Clause-by-Clause Training: £65/hour

  • Auditing Essentials: £65/hour

  • Introduction to EU MDR Regulatory Affairs: £100/hour

3.3.2 Delivery

  • Training sessions require advance scheduling

  • Materials remain the Company’s intellectual property

 

4. Fees & Payment

4.1 Invoicing

  • Invoices issued per Statement of Work milestones

  • Payment due within 30 days of invoice date

4.2 Rates

  • Consultancy: Rates as defined in Clause 3.2

  • Training: Rates as defined in Clause 3.3.1

4.3 Late Payments

  • Overdue invoices accrue interest at 8% p.a. above Bank of England base rate

  • Suspension of Services permitted for payments >60 days overdue

 

5. Confidentiality & Liability

5.1 Confidentiality

  • Both parties agree to protect proprietary information

  • Excludes publicly available or legally mandated disclosures

5.2 Liability Cap

  • Total liability limited to 100% of fees paid for relevant Services

  • Excludes liability for indirect/consequential losses

 

6. Termination

6.1 Termination Rights

  • Either party may terminate with 30 days’ written notice

  • Immediate termination for material breach

6.2 Post-Termination

  • Client pays for Services rendered prior to termination

  • Return of Confidential Information required

 

7. General Provisions

7.1 Governing Law

  • This Agreement is governed by English law

7.2 Dispute Resolution

  • Parties agree to mediate disputes before litigation

7.3 Force Majeure

  • Neither party is liable for delays caused by unforeseeable events

 

8. Company Details

QualiSure Consulting Ltd
Director: Carlos Maline
Bank: Starling Bank
UK Account: 78971217 (Sort: 60-83-71)
IBAN: GB05SRLG60837178971217
SWIFT: SRLGGB2L

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