WorkflowMergers, Spin-offs & Divestitures

Acquisition Quality System and Design File Integration

Quality system integration for an acquired device maker's files, read in the seller's numbering, mapped clause by clause to the buyer's procedures, with each gap owned before a family changes legal manufacturer.

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Follow one 510(k) gap from the yard to a signed plan ↓

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The problem

Instructions that claim a smaller vessel than either clearance allows

When a device company buys another, it inherits thousands of documents written to someone else's quality system: design history files, device master records, risk files, technical documentation, clearances, country registrations, supplier agreements and labels, all in the seller's numbering.

Before a product family can carry the buyer's name as legal manufacturer, each file has to be mapped to the buyer's procedures and each difference found, owned and fixed or carried knowingly. Design quality, regulatory and supplier quality engineers do this in spreadsheets, family by family, for months. A labeling change the seller called a clarification can slip through as a mapped document.

Built forIntegration program leadsRegulatory affairs leadsQuality integration leadsDesign quality engineers

The Problem Today

An acquired device maker's files arrive in its own numbering, and each family is mapped by hand before it can move.

30 days: to update FDA registration details after a change of owner published
1,030: hours of file mapping by hand for one 9-family deal our estimate

Mapped by hand today

Design
Risk
Clearances
Suppliers

Labels drift from clearancesInstructions can claim more than was ever cleared
Gaps without ownersA family moves with questions nobody holds

The Solution

Files sorted as they areEach document placed in its family and file set, in its own numbering
Mapped clause by clauseEach file matched to your procedure through its ISO 13485 clause
Mismatches citedCurrent instructions read beside each clearance, page by page
Each gap ownedOwner and date set by the right lead; a second person checks

Built-in controls

Signers open each source before signing
A family moves only when each gap is owned
Two people sign each family's transfer plan

What You Get

Integration teams move each family under their own name knowing what is open, who holds it, and why.

A proposal for each procedureKeep, adopt yours or retire, with the reason
Blocks that reach labelingUncleared wording stays out of your labels
A signed plan per familyWho, what, when, and what every signature stands for

Day 99 after close

A quality system integration morning: nine families, one clearance gap

A device maker closed on a vascular catheter maker 99 days ago, and the seller's data room holds 3,406 documents. Six families change legal manufacturer in the first wave, and their transfer plans are due in ten days.

demoAcquired company, its catheters, the clearances, the people and the documents are sample data.

0107:40
Nine families drawn as trains of eight file cars, nothing read yet
Integration PMO lead
Each family is a locomotive and eight cars: design file, master record, risk file, tech file, 510(k)s, countries, suppliers, and labels with identifiers. Before the read every car is gray with its document count, sorted in the seller's numbering. A status line says nothing has been read, and names the next step.
0208:12
48 cars couple on the first read and 24 stand apart with 57 gaps
Integration PMO lead
Agents read car by car. A car couples when its files map to the buyer's procedures with no open gap; otherwise it lifts, amber, with its gap count. Family 4, a catheter for peripheral arteries, has one car apart: the 510(k)s. No plan is ready yet, because 57 gaps have no owner, and owners are proposed on each car.
0308:15
Rev F says 3 to 10 mm; both clearances say 4 to 10
Regulatory affairs lead
He opens the car and the cited pages. Current instructions, revision F, page 2, put the catheter in peripheral arteries 3 to 10 mm in diameter. Both clearances, on their indications forms, say 4 to 10 mm. A change record from the seller called it a labeling clarification needing no submission. An agent cites all four pages and decides nothing.
0408:17
He owns the gap with a filing assessment, and rev F is blocked at once
Regulatory affairs lead
He chooses to assess a new 510(k) for 3 mm vessels and owns the gap, with a due date. Until it is cleared, the buyer's labels for the family carry the cleared 4 to 10 mm range. Two linked questions are named for him with the compliance lead, and the screen marks them as decisions it did not analyze.
0508:22
A second regulatory person opens the gap record and checks the log
Regulatory affairs manager
An owning lead cannot check his own log, so the car shows who checks it. She opens the gap record, reads his assessment against the four cited pages, and signs that the gap log is agreed. Its car stays coupled as owned, and a plan carrying this gap can now be signed.
0608:25
She approves the plan's filings, since its only assessment is his
Regulatory affairs manager
Family 4's transfer plan shows the train with 7 cars coupled and 1 owned, and the gap it carries. Each legal manufacturer change step has its citation: the 510(k) holder change, registration updates within 30 days, the certificate and declaration in the buyer's name. She opens the plan and approves the regulatory steps.
0708:30
Family 4 signed to move on the wave date with one gap open and owned
Integration PMO lead
She opens the plan, with the gap's pages in it, and signs with the meaning that the family moves on the wave date. One time is written for each signature, to the plan, the audit trail and the export. Reopening the plan would clear both signatures, and the export says unsigned draft until both are present.
0808:31
Back in the yard, one train sits on the main line
Integration PMO lead
Family 4's locomotive and rail are green and its 510(k) car shows one owned. Its status line counts 1 of 9 families signed and 56 gaps still without an owner, most of them on supplier cars. Next to sign is whichever family's gaps are owned and checked first.

Four gaps a mapping spreadsheet would have filed as mapped

A wider vessel range than cleared

Instructions rev F said 3 to 10 mm while both clearances said 4 to 10 mm.

Tested on one revision, released on the next

One catheter's verification report tested rev C while rev D was released.

A seal validated on one line, made on another

A pouch seal was validated on Line 2 and the product is made on Line 4.

A registration that lapses before its wave

One country registration expires before the second wave's change date.

demoSample data, from the working solution.

72 file cars and 57 gaps after the first read

Supplier gaps outnumber the written ones two to one.

Cars coupled on the first read	48
Cars apart	24
File cars across nine families	72
Written gaps in design, master, risk, technical, 510(k), country and label cars	19
Supplier gaps from 36 agreements27 agreements have no 90-day change notice and 9 need consent to assign; two serve two families.	38
Gaps to own before each family moves	57

demoSample data, from the working solution.

Around the transfer plans

Gaps, procedures and clearances behind each legal manufacturer change

What the regulatory, quality and supplier leads open while the plans are written.

Register of integration gaps filtered by state, family and file car, with owners, due dates and checks — **Gap register**All 57 gaps by state, family and car, with owner, due date and check. One is owned so far.

Acquired company's procedures mapped by ISO 13485 clause to the buyer's, each proposed to keep, adopt or retire — **61 procedures**Each of the seller's procedures by clause, with its counterpart and a proposal: keep 5, adopt 46, retire 6. A quality integration lead decides.

Clearances for each family with cleared indications compared to current instructions, and the holder change status — **Clearances and registrations**14 510(k)s with cleared indications beside the current instructions, and 210 registrations with holder and expiry.

Supplier agreements of the acquired company with findings for change notice and consent to assign, requests drafted — **140 agreements**104 transfer as written; 27 lack a change notice and 9 need consent to assign. A request is drafted for each, sent by a person.

Audit trail of a family transfer: gap owned, gap log checked, filings approved and transfer plan signed, with sessions — **Audit trail**Gap owned, log checked, the filings approved and the plan signed, each with its meaning and session.

demoSample data, from the working solution.

Who reads the data room

Six agents sort, map and cite; none of them owns or closes a gap

They read the files as they are and propose. Leads own, check and sign.

Data room inventory

Sorts each document into a family and file car in the seller's numbering.

Never renames or edits a document
Never opens complaint, MDR or vigilance files

Clause mapper

Maps each document and procedure to the buyer's procedure through its clause.

Never decides a proposal

Design file reader

Checks design, master, risk and technical files against the buyer's rules.

Never closes or relaxes a gap

Clearance and registration checker

Quotes cleared indications beside the current instructions and lists each registration's holder and expiry.

Never decides whether a filing is needed
Never says what a device may be used for

Supplier agreement reader

Reads agreements for assignment, consent and change notice, and drafts each request.

Never sends a request

Gap writer

Writes each gap with its pages, proposes an owner and due date, and drafts the change steps.

Never signs, owns, closes or dismisses

Who owns, checks and signs a family's move, and who only answers

Nobody checks a log that names them.

Integration PMO lead

Sees: Yard, each family's plan and what it carries
Signs: Signs each family's transfer plan, last

Regulatory affairs lead

Sees: Clearance, country, technical file and label gaps
Signs: Owns them with a filing assessment

Regulatory affairs manager

Sees: Each regulatory gap log and the plan's filing steps
Signs: Checks the logs; approves filings she made no assessment for

Quality integration lead

Sees: Procedure proposals and supplier requests, both passages side by side
Signs: Decides harmonization and sends supplier requests

Design quality engineer

Sees: Design, master record and risk file gaps
Signs: Owns them and asks the seller for missing records

Seller's quality manager

Sees: Questions from the buyer on a guest portal
Signs: Nothing: uploads records or says there are none

What integration leads ask about quality system integration

What is quality system integration after an acquisition?

It is the work of moving an acquired product family onto the buyer's quality system before the buyer becomes its legal manufacturer. Here quality system integration reads the seller's files as they are, maps each to the buyer's procedures by clause, and lists each gap with both pages for a named owner.

Does it decide whether a labeling difference needs a new clearance?

No. A clearance and registration checker quotes the cleared indications beside the current instructions. Then the regulatory affairs lead makes the filing assessment, and a second regulatory person checks it.

Can a family move with gaps still open?

Only when each gap it carries is owned and its log checked. Its plan is then approved for filings by a regulatory person who made none of its assessments, and signed by the integration lead.

What happens to the seller's procedures?

A clause mapper proposes keep, adopt the buyer's, or retire for each one, with both passages. A quality integration lead decides, and bulk adoptions are signed after opening a drawn sample.

Does it read the seller's complaint files?

No. That folder moves unopened to the buyer's complaint handling unit under one signed transfer record, and no agent reads it.

Can the seller's team see the plans?

No. A quality manager from the seller answers questions and uploads records on a guest portal and signs nothing. Plans, signatures and the audit trail stay with the buyer.

Mergers, Spin-offs & Divestitures