How much does implementing Dynamics 365 cost for a Life Science or Medtech company?

Implementation costs vary depending on system scope and regulatory requirements. A Business Central project for a mid-sized Medtech firm using pre-configured ISV add-ons (such as COSMO CONSULT or Yaveon) typically ranges from £80,000 to £200,000 in implementation services, plus CSV (Computer System Validation) costs. Larger Finance & Supply Chain Management (F&SCM) deployments for GxP-regulated pharmaceutical manufacturers usually cost between £300,000 and £1,000,000+ due to extensive validation, audit trail setups, and international supply chain requirements.

What are the biggest compliance risks when implementing ERP in a GxP environment?

The main risks stem from automated SaaS cloud updates violating Computer System Validation (CSV) protocols, poor electronic signature/audit trail management under FDA 21 CFR Part 11 / EU Annex 11, and inadequate partner expertise in regulatory standards like ISO 13485 or MDR/UDI. Choosing an implementation partner experienced in CSV and using validated ISV packages mitigates these risks significantly.

Should a Life Science business choose Business Central or Finance & Supply Chain Management?

Business Central (BC) is ideal for small-to-midmarket medtech or biotech firms that need core accounting, basic production, inventory lot control, and UDI integration with low administrative overhead. Finance & Supply Chain Management (F&SCM) is suited for larger pharmaceutical or medtech enterprises operating complex, multi-site global supply chains, advanced batch recipe manufacturing, and strict multi-entity regulatory requirements.

How does Dynamics 365 handle Post-Market Surveillance and field device servicing?

Dynamics 365 Field Service and Customer Service capture field maintenance records, equipment calibration logs, and customer complaints directly into an audit-proof system. This structured data links back to lot numbers and device IDs (UDI), enabling seamless CAPA (Corrective and Preventive Action) reporting required under MDR and FDA guidelines.

What are the best ISV add-ons for Life Science compliance in Dynamics 365?

Leading ISV solutions include COSMO Consult's Life Science modules (such as COSMO UDI and Quality Assurance) and Yaveon 365 Lot Management for Business Central. These pre-validated extensions provide out-of-the-box support for sample testing, electronic batch records, quality status management, and UDI barcode generation.

Dynamics 365 for Life Science & Medtech

Knowledge Hub | Industry guide

Life Science & Medtech

Workflows, system support, and an overview of listed partners — written from the buyer's perspective.

The Industry's Reality

Life Science and Medtech is one of the most demanding industries when selecting an ERP system. It is not primarily the complexity of the processes that makes it challenging — it is the regulatory requirements surrounding them. MDR, IVDR, ISO 13485, GxP, FDA 21 CFR Part 11: all impose strict requirements for complete traceability, audit trails, controlled document management, and, in many cases, Computer System Validation (CSV) for system updates. This means selecting a system in Life Science is not just about functionality, but about the capability to validate and maintain compliance over time.

Nordic Life Science companies span a broad spectrum — from global pharmaceutical enterprises with complex manufacturing processes and international supply chains to niche Medtech startups selling medical devices requiring field service, calibration, and Post-Market Surveillance. System requirements look fundamentally different depending on where you sit on this spectrum, making partner selection just as critical as system selection.

Microsoft Dynamics 365 is used across the industry both as a core ERP for finance, supply chain, and manufacturing, and as a platform for CRM and field service. The system can be validated for regulatory compliance and integrated with specialized QMS solutions via open APIs. Several partners listed on d365 Guide have developed industry-specific add-ons and pre-configured solutions that significantly reduce validation workload and implementation time.

Core Workflows and System Support

Finance & Supply Chain Management: Traceability, Production and Global Logistics

F&SCM is relevant for medium-sized to larger Life Science and Medtech businesses with complex requirements for batch/serial number traceability, production planning, and global supply chains. The system manages the full end-to-end chain from procurement of raw materials and components to manufacturing, warehouse management with expiration date controls, and distribution — with full traceability for UDI requirements and product recall processes.

Advanced warehouse management with batch and serial number tracking from supplier to customer
Traceability according to UDI (Unique Device Identification) across the entire value chain
Production planning for medical device manufacturers with embedded quality control checkpoints
Global supply chain management with customs handling, temperature control, and vendor approvals
Financial management and project accounting for R&D projects and clinical trials
Support for product recall processes with end-to-end tracking and regulatory reporting documentation

Business Central: ERP for SMBs in Life Science

Business Central suits small to mid-sized Life Science and Medtech companies that require an integrated system for finance, inventory, and logistics without the complexity of F&SCM. With the right industry-specific add-ons — for instance for batch management, quality assurance, and UDI — BC can meet regulatory demands for most SMB players in the sector.

Finance, purchasing, and inventory control within a unified workflow
Batch management and traceability via industry-specific add-ons
Integration with external QMS systems via open APIs
Project management for small-scale R&D and clinical trials

Field Service: Medical Equipment in the Field

For Medtech companies selling devices or equipment requiring installation, calibration, and ongoing maintenance, Field Service is critical — and in a regulatory context, it is non-negotiable. Service history, calibration logs, and maintenance documentation form part of regulatory compliance, and Field Service provides the digital audit trail required during regulatory inspections.

Service contracts and preventive maintenance schedules for medical devices
Digital documentation of calibration and field service actions with full traceability
Mobile access for field technicians with complete service history and work instructions
Connection to quality management systems for deviation handling and Post-Market Surveillance

Customer Service & Sales: Commercial Operations and Post-Market Surveillance

Sales in Life Science is complex: long sales cycles targeting hospitals and public health authorities, tender management, and contract lifecycle management require structured CRM support. Furthermore, Customer Service manages complaints and deviations as part of Post-Market Surveillance — a regulatory requirement demanding systematic collection and documentation of field product feedback.

Listed Partners in Life Science & Medtech

Four partners are listed for this industry on d365 Guide. Below, they are presented in the order they appear on the industry page.

COSMO CONSULT

Business Central, Sales, Customer Insights

COSMO CONSULT is a global Microsoft partner offering specialized industry solutions for Life Science and Medtech built on Business Central. They feature proprietary add-on modules specifically for the sector: COSMO UDI for traceability and UDI management under MDR, and COSMO Quality Assurance for quality test management in BC. The combination of global reach (1,600+ employees across 21 countries) and local presence with deep BC expertise and industry add-ons makes them one of the most specialized options in the directory for SMBs in Life Science.

Navet AB

Business Central, Sales, Customer Insights, Customer Service, Field Service, Contact Center | AI Integration Partner

Navet AB combines BC with industry-specific extensions for Life Science — including Yaveon 365 Lot Management for advanced batch tracking, traceability, and inventory flows. They also cover commercial customer relations with Sales, Customer Service, and Field Service, making them relevant for Medtech companies managing both supply chain and field service operations. Navet is part of the Aderian Group with a broad Nordic IT offering, and as an AI Integration Partner, they actively embed AI into their deliveries.

Implema AB

Finance, Supply Chain Management, Project Operations, Commerce, Human Resources

Implema is an F&SCM specialist focusing on finance, supply chain, project operations, and commerce. For Life Science companies needing support for complex logistics chains, R&D project control, and financial governance in a regulated environment, they deliver solid F&SCM expertise. While their profile is more generalist than dedicated Life Science specialist — lacking proprietary Life Science add-ons — they are a strong choice for organisations where advanced supply chain and project accounting take priority over specialized regulatory validation tools.

Choosing the Right Partner for Your Organisation

Life Science and Medtech is the industry on d365 Guide where the variance between partners is most pronounced. The difference between a pre-configured industry solution with built-in GxP compliance and computer system validation (CSV) support versus a standard implementation with custom modifications is fundamental — the former significantly reduces implementation risk and validation burden, though it is often sized for mid-market to enterprise organizations rather than early-stage startups.

COSMO CONSULT and Navet AB offer BC with specialized extensions for UDI, batch control, and quality assurance — highly relevant for SMBs. Implema brings deep F&SCM expertise for larger-scale supply chain and project requirements.

A central question during your partner evaluation should be: how does the partner approach computer system validation (CSV), and can they present reference clients who have successfully completed CSV for a Dynamics 365 implementation in a GxP-regulated environment? This question clearest distinguishes true Life Science specialists from generalist implementation partners.

Read more and compare partners on d365 Guide: d365 Guide - Life Science & Medtech