What software do medical device regulatory consultancies use to run client work?

Most run on a patchwork: a project or practice-management tool, shared drives, email, and spreadsheets for skills, representation mandates and invoices. That works until the firm grows past what one person can hold in their head. SMEDTEC OS gives consultancies one platform for enquiries, quotations, engagements and deliverables, the positions the practice has filed, a consultant network with skills and work orders, and Rep Hub for any representation mandates they hold, and it can be worked from an AI assistant through the SMEDTEC OS connector.

Last reviewed 2 November 2026 · SMEDTEC

Where the patchwork breaks

Generic project tools do not know what a deliverable is in regulatory terms, so reports go out without a document number or a version chain. The position the firm took on a borderline classification lives in one consultant's memory. CVs sit in a folder and skills in a sheet, so staffing a project means asking around. Each gap is small; together they cap how much work the firm can take on.

What a practice platform should hold

The pieces that matter are the ones generic tools cannot model.

Enquiry to quotation to engagement, with the scope and fee agreed kept against the client
Deliverables with document numbers, versions and approvals, from templates the firm owns
Filed positions, reviewed before anyone relies on them, that the firm's assistant answers from
A consultant network classified by sector, discipline, jurisdiction and credential, with work orders and invoices
Representation mandates with their obligations and dates, if the firm holds them

Working the practice from an AI assistant

SMEDTEC OS is exposed as an MCP connector, so an AI assistant that supports MCP connectors, such as Claude, can work on the same enquiry cards your team uses. You can capture an enquiry from an inbound email, record the agreed scope and fee, finalise the Quotation from your house template and mark it as sent, all from a conversation. Nothing the connector does sends email, terminates a mandate or deletes data.

A good fit for

Regulatory affairs and quality consultancies serving medical device manufacturers
Firms that use freelance consultants and want staffing, work orders and invoices in one place
Consultancies that also act as authorised representative or UK Responsible Person

Not the right tool for

Firms that only need time tracking and billing, which a general PSA tool covers

Common follow-up questions

Can a consultancy give clients access to their own work?

Yes, if the client wants it. A client can simply be a private record in the firm's workspace, with no login. A client who wants access can have a workspace the firm manages for them, where its contacts get read-only access to their own status and documents without seeing any other client.

What does practice software for a regulatory consultancy cost on SMEDTEC OS?

A one-person firm can run on the Free plan: up to three clients and one mandate, with the connector included. The Firm plan is £149 a month (or £1,490 a year) for three staff seats, unlimited clients and quotations and five mandates; Firm Plus is £349 a month for ten seats, twenty-five mandates, firm branding and the associate bench.

Does the consultancy's knowledge leak between clients?

No. Filed positions belong to the firm, and the Consultant Radar each consultant receives is built only from the public regulatory catalogue, never from client data.